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1.
Eur Child Adolesc Psychiatry ; 29(2): 153-165, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31054125

ABSTRACT

Suicidality in the child and adolescent population is a major public health concern. There is, however, a lack of developmentally sensitive valid and reliable instruments that can capture data on risk, and clinical and psychosocial mediators of suicidality in young people. In this study, we aimed to develop and assess the validity of instruments evaluating the psychosocial risk and protective factors for suicidal behaviours in the adolescent population. In Phase 1, based on a systematic literature review of suicidality, focus groups, and expert panel advice, the risk factors and protective factors (resilience factors) were identified and the adolescent, parent, and clinician versions of the STOP-Suicidality Risk Factors Scale (STOP-SRiFS) and the Resilience Factors Scale (STOP-SReFS) were developed. Phase 2 involved instrument validation and comprised of two samples (Sample 1 and 2). Sample 1 consisted of 87 adolescents, their parents/carers, and clinicians from the various participating centres, and Sample 2 consisted of three sub-samples: adolescents (n = 259) who completed STOP-SRiFS and/or the STOP-SReFS scales, parents (n = 213) who completed one or both of the scales, and the clinicians who completed the scales (n = 254). The STOP-SRiFS demonstrated a good construct validity-the Cronbach Alpha for the adolescent (α = 0.864), parent (α = 0.842), and clinician (α = 0.722) versions of the scale. Test-retest reliability, inter-rater reliability, and content validity were good for all three versions of the STOP-SRiFS. The sub-scales generated using Exploratory Factor Analysis (EFA) were the (1) anxiety and depression risk, (2) substance misuse risk, (3) interpersonal risk, (4) chronic risk, and (5) risk due to life events. For the STOP-SRiFS, statistically significant correlations were found between the Columbia-Suicide Severity Rating Scale (C-SSRS) total score and the adolescent, parent, and clinical versions of the STOP-SRiFS sub-scale scores. The STOP-SRiFS showed good psychometric properties. This study demonstrated a good construct validity for the STOP-SReFS-the Cronbach Alpha for the three versions were good (adolescent: α = 0.775; parent: α = 0.808; α = clinician: 0.808). EFA for the adolescent version of the STOP-SReFS, which consists of 9 resilience factors domains, generated two factors (1) interpersonal resilience and (2) cognitive resilience. The STOP-SReFS Cognitive Resilience sub-scale for the adolescent was negatively correlated (r = - 0.275) with the C-SSRS total score, showing that there was lower suicidality in those with greater Cognitive Resilience. The STOP-SReFS Interpersonal resilience sub-scale correlations were all negative, but none of them were significantly different to the C-SSRS total scores for either the adolescent, parent, or clinician versions of the scales. This is not surprising, because the items in this sub-scale capture a much larger time-scale, compared to the C-SSRS rating period. The STOP-SReFS showed good psychometric properties. The STOP-SRiFS and STOP-SReFS are instruments that can be used in future studies about suicidality in children and adolescents.


Subject(s)
Psychometrics/methods , Suicide/psychology , Adolescent , Female , Humans , Male , Reproducibility of Results , Risk Factors
2.
Eur Child Adolesc Psychiatry ; 29(6): 759-776, 2020 Jun.
Article in English | MEDLINE | ID: mdl-30684089

ABSTRACT

Suicidality in childhood and adolescence is of increasing concern. The aim of this paper was to review the published literature identifying key psychosocial risk factors for suicidality in the paediatric population. A systematic two-step search was carried out following the PRISMA statement guidelines, using the terms 'suicidality, suicide, and self-harm' combined with terms 'infant, child, adolescent' according to the US National Library of Medicine and the National Institutes of Health classification of ages. Forty-four studies were included in the qualitative synthesis. The review identified three main factors that appear to increase the risk of suicidality: psychological factors (depression, anxiety, previous suicide attempt, drug and alcohol use, and other comorbid psychiatric disorders); stressful life events (family problems and peer conflicts); and personality traits (such as neuroticism and impulsivity). The evidence highlights the complexity of suicidality and points towards an interaction of factors contributing to suicidal behaviour. More information is needed to understand the complex relationship between risk factors for suicidality. Prospective studies with adequate sample sizes are needed to investigate these multiple variables of risk concurrently and over time.


Subject(s)
Suicide/psychology , Adolescent , Child , Female , Humans , Male , Prospective Studies , Psychology , Risk Factors
3.
BMC Pediatr ; 16(1): 213, 2016 12 13.
Article in English | MEDLINE | ID: mdl-27964729

ABSTRACT

BACKGROUND: To create a self-reported, internet-based questionnaire for the assessment of suicide risk in children and adolescents. METHODS: As part of the EU project 'Suicidality: Treatment Occurring in Paediatrics' (STOP project), we developed web-based Patient Reported Outcome Measures (PROMs) for children and adolescents and for proxy reports by parents and clinicians in order to assess suicidality. Based on a literature review, expert panels and focus groups of patients, we developed the items of the STOP Suicidality Assessment Scale (STOP-SAS) in Spanish and English, translated it into four more languages, and optimized it for web-based presentation using the HealthTrackerTM platform. Of the total 19 questions developed for the STOP-SAS, four questions that assess low-level suicidality were identified as screening questions (three of them for use with children, and all four for use with adolescents, parents and clinicians). A total of 395 adolescents, 110 children, 637 parents and 716 clinicians completed the questionnaire using the HealthTrackerTM, allowing us to evaluate the internal consistency and convergent validity of the STOP-SAS with the clinician-rated Columbia Suicide Severity Rating Scale (C-SSRS). Validity was also assessed with the receiver operating characteristic (ROC) area of the STOP-SAS with the C-SSRS. RESULTS: The STOP-SAS comprises 19 items in its adolescent, parent, and clinician versions, and 14 items in its children's version. Good internal consistency was found for adolescents (Cronbach's alpha: 0.965), children (Cronbach's alpha: 0.922), parents (Cronbach's alpha: 0.951) and clinicians (Cronbach's alpha: 0.955) versions. A strong correlation was found between the STOP-SAS and the C-SSRS for adolescents (r:0.670), parents (r:0.548), clinicians (r:0.863) and children (r:0.654). The ROC area was good for clinicians' (0.917), adolescents' (0.834) and parents' (0.756) versions but only fair (0.683) for children's version. CONCLUSIONS: The STOP-SAS is a comprehensive, web-based PROM developed on the HealthTrackerTM platform, and co-designed for use by adolescents, children, parents and clinicians. It allows the evaluation of aspects of suicidality and shows good reliability and validity.


Subject(s)
Psychiatric Status Rating Scales , Suicide Prevention , Adolescent , Child , Female , Focus Groups , Humans , Internet , Male , Patient Reported Outcome Measures , Pediatrics , Psychometrics , ROC Curve , Reproducibility of Results , Risk Assessment , Self Report , Suicide/psychology
4.
BMJ Open ; 6(4): e010433, 2016 Apr 26.
Article in English | MEDLINE | ID: mdl-27118284

ABSTRACT

INTRODUCTION: Methylphenidate is the most frequently used medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in Europe. Following concerns about its safety, the European Commission called for research into the long-term effects of methylphenidate on children and adolescents with ADHD. The Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) research programme was designed to address this call. At the heart of this programme is a 2-year longitudinal naturalistic pharmacovigilance study being conducted in 27 European sites. METHODS AND ANALYSIS: 3 cohorts of children and adolescents (aged 6-17) living in the UK, Germany, Italy and Hungary are being recruited:Group 1 (Medicated ADHD): 800 ADHD medication-naive children and adolescents with a clinical diagnosis of ADHD about to start methylphenidate treatment for the first time.Group 2 (Unmedicated ADHD): 400 children and adolescents with a clinical diagnosis of ADHD who have never been treated with ADHD medication and have no intention of beginning medication.Group 3 (Non-ADHD): 400 children and adolescents without ADHD who are siblings of individuals in either group 1 or 2.All participants will be assessed 5 times during their 2-year follow-up period for growth and development, psychiatric, neurological and cardiovascular health. The primary outcome measure will be the height velocity SD score. ETHICS AND DISSEMINATION: Ethical approval for the study has been granted by the East of Scotland Research Ethics Service. Following this approval, patient information leaflets and consent forms were translated as necessary and submissions made by lead sites in each of the other 3 countries to their own ethics committees. Following ethical approval in each country, local ethical permissions at each site were sought and obtained as needed. The study's website (http://www.adhd-adduce.org/page/view/2/Home) provides information for researchers, participants and the general public. TRIAL REGISTRATION NUMBER: NCT01470261.


Subject(s)
Attention Deficit Disorder with Hyperactivity/drug therapy , Central Nervous System Stimulants/administration & dosage , Central Nervous System Stimulants/adverse effects , Methylphenidate/administration & dosage , Methylphenidate/adverse effects , Adolescent , Child , Female , Germany , Humans , Hungary , Italy , Logistic Models , Longitudinal Studies , Male , Pharmacovigilance , Prospective Studies , Treatment Outcome , United Kingdom
5.
Nervenarzt ; 87(4): 367-75, 2016 Apr.
Article in German | MEDLINE | ID: mdl-26992908

ABSTRACT

BACKGROUND: The European Union (EU) regulation 1901/2006 plus the implementation of pediatric investigational plans by the European Medicines Agency (EMA) have contributed to more clinical studies in pediatric psychopharmacology. A new drug market law (AMNOG) has been in force in Germany since 2011 that requires an additional process of assessment of benefits of newly authorized medications by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G­BA), which also holds for medications licensed for pediatric populations. OBJECTIVES: Summary of early assessments of benefits for newly registered compounds in the treatment of psychiatric disorders and critical discussion from the perspective of child and adolescent psychiatry. MATERIAL AND METHODS: Application and critical review of documents and written statements by various institutions and stakeholders related to assessment procedures and respective decisions by the G­BA for these medications. RESULTS AND CONCLUSION: Clearly differing requirements for study designs and outcome parameters characterize the conditions for market authorization and for the assessment of benefits. Further adjustments to the regulations in implementing the AMNOG appear to be essential, integrating agencies involved so far, complimented by expertise from regulatory agencies and medical scientific societies.


Subject(s)
Adolescent Psychiatry/legislation & jurisprudence , Child Psychiatry/legislation & jurisprudence , Drug Industry/legislation & jurisprudence , Health Care Reform/legislation & jurisprudence , Marketing of Health Services/legislation & jurisprudence , Psychopharmacology/legislation & jurisprudence , Drug Approval/economics , Drug Approval/legislation & jurisprudence , Europe , Germany , Health Care Reform/economics , Legislation, Drug , Marketing of Health Services/economics , Outcome Assessment, Health Care/economics , Outcome Assessment, Health Care/legislation & jurisprudence , Psychotherapy/economics , Psychotherapy/legislation & jurisprudence , Psychotropic Drugs , Quality Assurance, Health Care/economics , Quality Assurance, Health Care/legislation & jurisprudence
6.
Fortschr Neurol Psychiatr ; 83(12): 676-85, 2015 Dec.
Article in German | MEDLINE | ID: mdl-26714249

ABSTRACT

Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder - which may persist into adolescence and adulthood. Psychostimulants and atomoxetine (ATX) are frequently prescribed to treat ADHD in Germany. Lisdexamfetamine dimesylate (LDX) is the most recently approved ADHD medication in Germany and other European countries. Data used to support the European registration of LDX is summarised from three phase-3/3b studies in children and adolescents with ADHD. Short-term efficacy (study SPD489 - 325), maintenance of efficacy (study SPD489 - 326) and efficacy in patients who had previously responded inadequately to methylphenidate (MPH) treatment (study SPD489 - 317) were demonstrated. The safety and tolerability profile of LDX in all three European studies was shown to be in line with that of other psychostimulants used to treat patients with ADHD.


Subject(s)
Attention Deficit Disorder with Hyperactivity/drug therapy , Central Nervous System Stimulants/therapeutic use , Lisdexamfetamine Dimesylate/therapeutic use , Adolescent , Child , Clinical Trials, Phase III as Topic , Europe , Germany , Humans
7.
Pharmacopsychiatry ; 46(1): 23-8, 2013 Jan.
Article in English | MEDLINE | ID: mdl-22699956

ABSTRACT

INTRODUCTION: This report describes difficulties encountered when attempting to recruit children and adolescents with major depression for a recent international double-blind, placebo-controlled trial (www.clinicaltrials.gov Nr. NCT00849901). METHODS: Over a 14-month period, children and adolescents with depressive symptoms were pre-screened for their eligibility for inclusion. RESULTS: 85 patients (age 7-17 years) were considered. Of these, only one was enrolled. The main reasons for non-eligibility were: failure to meet the baseline severity criterion on the primary outcome scale (clinical global impression-severity; 32.1% of the patients); requirement for immediate hospitalisation (15.4%); or the presence of an exclusionary comorbid psychiatric disorder (19.1%). DISCUSSION: The recruitment of paediatric patients with major depression was primarily limited by various inclusion and exclusion criteria. Slow recruitment of small patient samples may impact strongly on the representativeness and generalisability of research findings, and thus on analyses in evidence-based medicine and on the development and recommendations of treatment guidelines. This may impact in turn on the feasibility of the clinical development and registration process of new compounds in paediatric psychopharmacology and beyond.


Subject(s)
Depressive Disorder, Major/drug therapy , Multicenter Studies as Topic/methods , Patient Selection , Adolescent , Child , Depressive Disorder, Major/psychology , Double-Blind Method , Female , Hospitalization , Humans , Male , Neuropsychological Tests , Patient Compliance , Research Design , Suicide, Attempted , Treatment Outcome
8.
Eur Psychiatry ; 28(6): 379-85, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23062837

ABSTRACT

PURPOSE: To investigate effects of a 12-week treatment with atomoxetine (ATX) on driving performance in real traffic, driving-related neuropsychological performance tests and self-evaluation of driving in adult patients with ADHD compared to an untreated control group with ADHD. METHODS: Parallel group design with an ATX and a waiting list group. At baseline and endpoint patients were evaluated with a standardized on-road driving test (SDBO), a driving-related neuropsychological test battery (Act and React Test System [ART2020]), and subjective measures of driving performance (one-week driving diary, Driver Coping Questionnaire). RESULTS: Forty-three of the 64 included patients completed the study (n=22 ATX, n=21 controls). Mean intervention period was 11.9±3.0 weeks, mean daily ATX dosage was 71.6±14.9mg. At endpoint, 60.1% of patients treated with ATX and 0% of waiting list group had reduced ADHD symptoms by greater or equal to 30%. In SDBO, ATX group reduced driving errors in three of four driving performance categories (attention, P<0.05; risk-related self-control, P<0.005; driver skills, P<0.001), number of driving errors remained stable in control group. At endpoint, 47.6% of control group and 18.2% of ATX group (P<0.05) did not fulfil the driving fitness criteria according to German Guidelines (percentile rank less or equal to 16 in one or more subtests in ART2020). Total number of self-reported critical traffic situations decreased from 12.0 to 6.8 per week in ATX group (P<0.05) and remained stable in controls by 9.3 and 9.9 at baseline and endpoint (ns). Coping strategies with stressful traffic situations did not change within both groups. CONCLUSION: Our study provides first evidence that treatment with ATX improves driving performance in real traffic in adults with ADHD.


Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention/drug effects , Automobile Driving , Propylamines/therapeutic use , Adolescent , Adrenergic Uptake Inhibitors/pharmacology , Adult , Atomoxetine Hydrochloride , Female , Humans , Male , Middle Aged , Propylamines/pharmacology , Reaction Time/drug effects , Surveys and Questionnaires , Treatment Outcome , Waiting Lists
9.
Pharmacopsychiatry ; 45(3): 100-7, 2012 May.
Article in English | MEDLINE | ID: mdl-22174029

ABSTRACT

BACKGROUND: With the increasing recognition of adult attention-deficit/hyperactivity disorder (ADHD) there is an emerging need to investigate medication in this population. METHODS: In this waiting list-controlled trial, 64 ADHD-patients (mean age 35.8 ± 8.7 years) were randomly assigned to a daily dosage of up to 80 mg atomoxetine (Atx) or waiting list for 12-weeks. Primary outcome was the change of the observer-rated DSM-IV total ADHD score on the Conners' Adult ADHD Rating Scales (CAARSO: L DSM-IV total ADHD score) from baseline to endpoint. Other efficacy measures included selfrated CAARS-S:L DSM-IV total ADHD score, CAARS-O/S:L problems with self-concept and emotional lability score, Wender-Reimherr Adult Attention Defi cit Disorder Scale Emotional Dysregulation Score, and General Activities Score on the Quality of Life Enjoyment and Satisfaction Questionnaire. Efficacy measures were analysed in the per-protocol population. RESULTS: Mean change in CAARS:O-L DSM-IV total ADHD score was -13.1 ± 7.7 in the Atx vs. -0.4 ± 4.8 in the control group (p < 0.005). Treatment response ( ≥ 30 % reduction) was 60.1 % in the Atx vs. 0 % in the waiting list group. The other efficacy measures also showed significant improvements. The overall incidence of adverse events (AEs) was 70.4 % in the Atx group, the most frequent included fatigue, irritability, nausea and decreased appetite. In Atx-treated patients 18.5 % discontinued early due to AEs. DISCUSSION: Our results suggest that Atx is an effective treatment in adult ADHD. It reduces ADHD core and associated emotional symptoms and increases self-esteem and quality of life. AEs were consistent with those reported in other studies in adult ADHD.


Subject(s)
Adrenergic Uptake Inhibitors/administration & dosage , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit Disorder with Hyperactivity/psychology , Propylamines/administration & dosage , Adolescent , Adrenergic Uptake Inhibitors/adverse effects , Adult , Atomoxetine Hydrochloride , Female , Humans , Male , Middle Aged , Patient Satisfaction , Propylamines/adverse effects , Quality of Life , Self Concept , Treatment Outcome , Waiting Lists , Young Adult
10.
Eur Child Adolesc Psychiatry ; 20(1): 17-37, 2011 Jan.
Article in English | MEDLINE | ID: mdl-21042924

ABSTRACT

The safety of ADHD medications is not fully known. Concerns have arisen about both a lack of contemporary-standard information about medications first licensed several decades ago, and signals of possible harm arising from more recently developed medications. These relate to both relatively minor adverse effects and extremely serious issues such as sudden cardiac death and suicidality. A guidelines group of the European Network for Hyperkinetic Disorders (EUNETHYDIS) has therefore reviewed the literature, recruited renowned clinical subspecialists and consulted as a group to examine these concerns. Some of the effects examined appeared to be minimal in impact or difficult to distinguish from risk to untreated populations. However, several areas require further study to allow a more precise understanding of these risks.


Subject(s)
Attention Deficit Disorder with Hyperactivity/drug therapy , Cardiovascular Diseases/chemically induced , Cardiovascular Diseases/prevention & control , Central Nervous System Stimulants/adverse effects , Monitoring, Physiologic , Propylamines/adverse effects , Suicide, Attempted/prevention & control , Adrenergic Uptake Inhibitors/administration & dosage , Adrenergic Uptake Inhibitors/adverse effects , Atomoxetine Hydrochloride , Attention Deficit Disorder with Hyperactivity/psychology , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/mortality , Central Nervous System Stimulants/administration & dosage , Child , Clinical Trials as Topic , Drug Administration Schedule , Drug Dosage Calculations , Drug Tolerance , Drug Utilization Review , Europe , Humans , Monitoring, Physiologic/methods , Monitoring, Physiologic/standards , Propylamines/administration & dosage , Risk Assessment , Substance-Related Disorders/etiology , Substance-Related Disorders/prevention & control , Suicide, Attempted/psychology
11.
Acta Psychiatr Scand ; 118(3): 220-9, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18699954

ABSTRACT

OBJECTIVE: Few studies have prospectively examined remission and recovery as well as their predictors in schizophrenia simultaneously. Aims of the study were to identify remission and recovery rates as well as their predictors in schizophrenia. METHOD: 392 never-treated patients with schizophrenia were assessed over 3 years. Combined remission and recovery required concurrent achievement of symptomatic and functional remission as well as adequate quality of life for at least 6 and 24 months respectively. Predictors were analysed using stepwise logistic regression models. RESULTS: At 3 years, remission rates for symptoms, functioning and subjective wellbeing were 60.3%, 45.4% and 57.0%; recovery rates were 51.7%, 35.0% and 44.3%. Of those, 28.1% were in combined remission and 17.1% in combined recovery. Predictors mainly included the baseline functional status and early remission within the first 3 months. CONCLUSION: The proportion of patients who met combined remission or recovery criteria is low. Early treatment adaptations in case of early non-remission are mandatory.


Subject(s)
Schizophrenia/epidemiology , Adult , Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Employment/psychology , Female , Follow-Up Studies , Germany/epidemiology , Humans , Male , Middle Aged , Olanzapine , Predictive Value of Tests , Prospective Studies , Psychiatric Status Rating Scales/statistics & numerical data , Quality of Life , Remission, Spontaneous , Schizophrenia/drug therapy , Schizophrenic Psychology , Social Behavior , Treatment Outcome , Young Adult
12.
Nervenarzt ; 77(3): 294, 297-300, 302-4 passim, 2006 Mar.
Article in German | MEDLINE | ID: mdl-16133434

ABSTRACT

This paper gives an overview of the pharmacology, efficacy, duration, tolerance, and side effects of atomoxetine for children, adolescents, and adults. A systematic analysis of the published clinical studies and poster abstracts was conducted. Atomoxetine is the first selective inhibitor of the noradrenaline transporter that was approved by the FDA in the US as a nonstimulant for the treatment of ADHD in children, adolescents, and adults. In clinical studies, its efficacy was studied in 4,000 patients. Compared with placebo, atomoxetine proved to be superior with respect to reducing impulsiveness, hyperactivity, and inattention. There are indications that its efficacy is comparable to that of methylphenidate. In general, atomoxetine was well tolerated. The most frequently reported adverse events were decrease of appetite, abdominal problems, tiredness, and vertigo. These were classified as mild and found mostly at the beginning of treatment. The existing results indicate that atomoxetine is promising for the treatment of ADHD in children, adolescents, and adults.


Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Attention Deficit Disorder with Hyperactivity/drug therapy , Norepinephrine Plasma Membrane Transport Proteins/antagonists & inhibitors , Propylamines/therapeutic use , Adolescent , Adrenergic Uptake Inhibitors/adverse effects , Adult , Atomoxetine Hydrochloride , Child , Clinical Trials as Topic , Humans , Methylphenidate/adverse effects , Methylphenidate/therapeutic use , Propylamines/adverse effects , United States , United States Food and Drug Administration
13.
Pharmacopsychiatry ; 38(1): 6-12, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15706459

ABSTRACT

INTRODUCTION: The aim of the study was to assess the feasibility of abruptly switching inadequately treated psychotic outpatients from another oral antipsychotic to olanzapine and to evaluate subjective well-being under olanzapine. METHODS: Previous medication was switched to olanzapine 10 mg/day and continued for 4 weeks (5-20 mg/day). Successful switch was predefined as no change or any improvement on the Clinical Global Impression-Improvement (CGI-I) scale after one week. A successful switch rate of > or = 70 % was considered a positive study outcome. Well-being was evaluated using the Subjective Well-being under Neuroleptics (SWN) scale. RESULTS: 198 patients (100 %) were switched to olanzapine. In 177 patients (89 %), CGI-I was unchanged (29 %) or improved (60 %) after one week of olanzapine treatment, indicating a positive study outcome (p < 0.001). SWN total score significantly improved from 127.9 (+/- 32.5) at baseline to 139.2 (+/- 31.5) at week 1, continuing to 149.3 (+/- 30.3) at week 4 (LOCF). DISCUSSION: The findings suggest that an abrupt switch from another antipsychotic to olanzapine 10 mg/day can be performed successfully in psychotic patients, while rapidly improving subjective well-being.


Subject(s)
Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Schizophrenia/drug therapy , Adolescent , Adult , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/adverse effects , Benzodiazepines/administration & dosage , Benzodiazepines/adverse effects , Female , Humans , Male , Olanzapine , Prospective Studies , Psychiatric Status Rating Scales , Schizophrenic Psychology , Treatment Outcome
14.
Pharmacopsychiatry ; 38(1): 13-6, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15706460

ABSTRACT

INTRODUCTION: Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), and trimipramine, a tricyclic antidepressant (TCA), were compared in terms of efficacy and tolerability in a six-week, parallel group, double-blind pilot study in 41 geriatric patients with major depression (61 - 85 years old). METHOD: The Hamilton Rating Scale for Depression (HAMD-17), the Montgomery-Asberg Rating Scale (MADRS), the Adjective Mood Scale (Bf-S), the Clinical Global Impression (CGI), and the Patients Global Impression (PGI) were used to measure changes in depressive symptoms. RESULTS: Improvement with treatment was found on all scales. Efficacy and tolerability were similar in both groups. No statistically significant differences were found. CONCLUSION: These findings suggest that fluoxetine and trimipramine are comparable in terms of efficacy and tolerability in the treatment of major depression in geriatric patients.


Subject(s)
Antidepressive Agents, Second-Generation/therapeutic use , Antidepressive Agents, Tricyclic/therapeutic use , Depressive Disorder, Major/drug therapy , Fluoxetine/therapeutic use , Trimipramine/therapeutic use , Aged , Aged, 80 and over , Antidepressive Agents, Second-Generation/adverse effects , Antidepressive Agents, Tricyclic/adverse effects , Depressive Disorder, Major/psychology , Double-Blind Method , Female , Fluoxetine/adverse effects , Humans , Male , Middle Aged , Prospective Studies , Psychiatric Status Rating Scales , Trimipramine/adverse effects
15.
Acta Psychiatr Scand ; 111(2): 106-15, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15667429

ABSTRACT

OBJECTIVE: This randomized double-blind multicenter trial evaluated the effects of olanzapine vs. clozapine on subjective well-being, quality of life (QOL) and clinical outcome. METHOD: The primary objective was to demonstrate non-inferiority of olanzapine, mean dosage 16.2 +/- 4.8 (5-25 mg/day) vs. clozapine, mean dosage 209 +/- 91 (100-400 mg/day) regarding improvement on the 'Subjective Well-Being under Neuroleptic Treatment' (SWN) Scale after 26 treatment weeks in 114 patients with schizophrenia. Secondary outcome parameters included: Munich QOL Dimension List (MLDL), Positive and Negative Symptom Scale (PANSS), Clinical Global Impression (CGI). RESULTS: SWN scores improved significantly in both groups, olanzapine was non-inferior to clozapine (group difference 3.2 points in favor of olanzapine; 95% CI: 4.2;10.5). MLDL-satisfaction, PANSS and CGI-S improved similarly, olanzapine yielded a higher CGI Therapeutic Index. Individual SWN and PANSS changes correlated only moderately (r = -0.45). CONCLUSION: Olanzapine was non-inferior to clozapine. The lack of a marked correlation between PANSS and SWN improvements indicates that patients and psychiatrists perceive treatment differently.


Subject(s)
Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Clozapine/therapeutic use , Quality of Life , Schizophrenia/drug therapy , Adolescent , Adult , Antipsychotic Agents/administration & dosage , Benzodiazepines/administration & dosage , Brief Psychiatric Rating Scale , Clozapine/administration & dosage , Diagnostic and Statistical Manual of Mental Disorders , Double-Blind Method , Female , Humans , Male , Middle Aged , Olanzapine , Schizophrenia/diagnosis , Severity of Illness Index , Treatment Outcome
16.
Pharmacopsychiatry ; 37(6): 279-85, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15551194

ABSTRACT

OBJECTIVE: The atypical antipsychotic olanzapine has extensively been compared with haloperidol, whereas studies vs. other (conventional) neuroleptics are scarce. This exploratory double-blind 4-week study was designed to compare the efficacy and the safety of olanzapine (OLA) and flupenthixol (FLU) which have recently been considered as a "partially atypical" antipsychotics. METHODS: Twenty-eight inpatients with schizophrenia (DSM-IV) were randomly assigned for treatment with OLA (N = 15, 5-20 mg/d) or FLU (N = 13, 5-20 mg/d). The Brief Psychiatric Rating Scale (BPRS) and the Negative Symptoms Rating Scale (NSRS), plus the Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales, were used to assess the efficacy of both compounds; safety was determined by using the Simpson Angus Scale (SAS) and the Abnormal Involuntary Movement Scale (AIMS) and by assessing treatment-emergent adverse events. Non-parametric statistics were applied. RESULTS: BPRS and NSRS scores improved in both groups (exploratory tests; all p < or = 0.02). Similar results were observed for CGI-Severity, CGI- and PGI-Improvement. There were no significant group differences. Responder rates (at least 40 % decrease in BPRS total) were 9/13 OLA patients (69 %) and 9/12 FLU patients (75 %). EPS events were reported only in the FLU group (p < 0.01); FLU patients needed significantly more anticholinergic medication. Weight gain was higher in OLA patients (p < 0.01). Overall, fewer patients with adverse events were observed in the OLA group (p = 0.04). No significant changes were noted on SAS and AIMS scores. CONCLUSION: Findings from this study suggest that overall and negative symptomatology improved in both treatment groups, while the safety and tolerability profiles differed for both substances.


Subject(s)
Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Flupenthixol/therapeutic use , Inpatients , Schizophrenia/drug therapy , Adult , Brief Psychiatric Rating Scale , Case-Control Studies , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Olanzapine , Treatment Outcome
17.
Pharmacopsychiatry ; 37(4): 157-62, 2004 Jul.
Article in English | MEDLINE | ID: mdl-15467971

ABSTRACT

BACKGROUND: It is well known that sleep disturbance is an integral symptom of schizophrenia. In recent studies, a deficit of delta sleep has been observed in schizophrenic patients. Antipsychotic drugs with serotonin (5-HT2) receptor-antagonistic properties are considered to have delta sleep promoting effects. We have investigated the effects of subchronic olanzapine treatment on sleep EEG in schizophrenic patients. METHODS: The effects of administration of olanzapine (15 to 20 mg) on sleep were studied for four weeks in 10 male, drug-free patients suffering from schizophrenia with predominantly negative symptoms. Conventional sleep EEG parameters were investigated at baseline and after treatment with olanzapine for four weeks. Additionally, spectral power analysis of the EEG signal in distinct frequency bands was computed for different sleep stages. Psychopathology (PANSS, HAMD-17, HAMA) and side effects were assessed weekly. RESULTS: All patients improved, as measured by PANSS global scores. Compared to baseline, there was a significant improvement of parameters of sleep efficiency and an increase of delta sleep as well as REM sleep. Regarding spectral power values, no significant differences between baseline and treatment conditions were found. CONCLUSIONS: Sleep improvement was due to parameters of sleep efficiency and delta sleep, which may be related to serotonin antagonistic properties of olanzapine.


Subject(s)
Antipsychotic Agents/pharmacology , Benzodiazepines/pharmacology , Electroencephalography/drug effects , Schizophrenia/drug therapy , Schizophrenic Psychology , Sleep Stages/drug effects , Adolescent , Adult , Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Delta Rhythm , Diagnostic and Statistical Manual of Mental Disorders , Drug Administration Schedule , Humans , Male , Middle Aged , Olanzapine , Polysomnography , Schizophrenia/diagnosis , Severity of Illness Index , Surveys and Questionnaires
18.
Int J Methods Psychiatr Res ; 11(1): 19-26, 2002.
Article in English | MEDLINE | ID: mdl-12459801

ABSTRACT

The Dementia Checklist is a 12-item dementia rating scale for physicians who, for whatever reason, cannot be specifically trained. It addresses symptoms of cognitive decline that can easily be identified, and that are typical for different stages of cognitive impairment. This allows an easy classification of the severity of dementia. In a first study, the dementia checklist was used in 937 geriatric outpatients who were treated by neuropsychiatrists for depression. All items contribute to the accuracy of measurement (Cronbach's alpha = 0.84). Differences in cognitive impairment depending on age (chi 2 = 51.7; p < or = 0.001) and depression (chi 2 = 47.6; p < or = 0.001) indicate external validity of the dementia checklist and 5.7% of the outpatients were rated as demented. The Dementia Checklist provides a very economical and easy-to-use assessment of cognitive decline.


Subject(s)
Cognition Disorders/diagnosis , Dementia/diagnosis , Depressive Disorder/complications , Age Factors , Aged , Aged, 80 and over , Cognition Disorders/complications , Cognition Disorders/psychology , Dementia/psychology , Female , Geriatric Assessment , Humans , Male , Middle Aged , Neuropsychological Tests , Outpatients , Primary Health Care/standards , Psychiatric Status Rating Scales , Sex Factors
19.
Eur Child Adolesc Psychiatry ; 10(2): 151-7, 2001 Jun.
Article in English | MEDLINE | ID: mdl-11469288

ABSTRACT

Psychopathology in severely anorexic patients often seems to be of compulsive and delusional quality rendering therapeutic approaches extremely difficult. With conventional therapeutic regimes failing, administration of the novel antipsychotic olanzapine induced remarkable improvement in five cases reported here. Paranoid ideation concerning body image or weight gain decreased and sedative effects helped to reduce inner tensions and phobia with respect to food intake. Olanzapine, therefore, might represent an important therapeutic tool in anorexic patients who present the following characteristics: long-term history of anorexia nervosa mostly with several hospitalisations, missing perception of their severe state of illness, refusal of therapy, delusional quality of anorexic thinking, risk of discontinuation of therapy with life-threatening consequences.


Subject(s)
Anorexia Nervosa/drug therapy , Pirenzepine/analogs & derivatives , Pirenzepine/therapeutic use , Adolescent , Anorexia Nervosa/psychology , Benzodiazepines , Body Image , Child , Delusions/drug therapy , Delusions/psychology , Female , Humans , Olanzapine , Patient Compliance/psychology , Perceptual Distortion , Pirenzepine/adverse effects , Treatment Outcome
20.
Pharmacopsychiatry ; 34(2): 60-5, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11302565

ABSTRACT

The effects of trimipramine, a tricyclic antidepressant (TCA) with atypical pharmacological properties, and fluoxetine, a selective serotonine reuptake inhibitor (SSRI), were compared in an exploratory analysis using mood and polysomnographic parameters during a six-week double-blind trial in 19 depressed geriatric patients. In sleep EEG measures, trimipramine demonstrated clear-cut effects on sleep measures resulting in higher values for sleep efficiency, total sleep time, stage 2 sleep, and shorter wake time. Under fluoxetine treatment, the proportion of REM sleep was decreased and REM latency was lengthened, whereas no change in REM sleep parameters was observed in the trimipramine group. The present data suggest that early antidepressant effects of medication occur independently of drug-induced changes in objective measures of sleep, i.e. suppression of REM sleep.


Subject(s)
Antidepressive Agents, Second-Generation/therapeutic use , Antidepressive Agents, Tricyclic/therapeutic use , Depressive Disorder/drug therapy , Fluoxetine/therapeutic use , Sleep/drug effects , Trimipramine/therapeutic use , Affect/drug effects , Aged , Antidepressive Agents, Second-Generation/adverse effects , Antidepressive Agents, Tricyclic/adverse effects , Depressive Disorder/psychology , Double-Blind Method , Female , Fluoxetine/adverse effects , Humans , Male , Middle Aged , Polysomnography/drug effects , Psychiatric Status Rating Scales , Sleep Stages/drug effects , Sleep, REM/drug effects , Trimipramine/adverse effects
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