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1.
J Child Adolesc Psychopharmacol ; 28(1): 47-54, 2018 02.
Article in English | MEDLINE | ID: mdl-29035574

ABSTRACT

OBJECTIVES: In this 6-month open-label extension (OLE) of NCT01491035 (a 14-day, open-label, pharmacokinetic/safety lead-in study), the long-term safety and tolerability of vortioxetine (5-20 mg/day) were investigated in children and adolescents with a DSM-IV-TR™ diagnosis of depressive or anxiety disorder in the United States or Germany. The study also was designed to provide data to inform dose selection and titration in future pediatric studies with vortioxetine. METHODS: Safety evaluations included spontaneously reported adverse events (AEs), the Columbia Suicide Severity Rating Scale (C-SSRS), and the Pediatric Adverse Events Rating Scale (PAERS; clinician administered). Clinical effectiveness was determined by Clinical Global Impressions. Comorbid attention-deficit/hyperactivity disorder was permitted, including concomitant use of stimulant medication (US sites only). RESULTS: Of the 47 patients who completed the lead-in period, 41 continued into the OLE. Most patients (n = 39 [95%]) continued their previous dose regimen. Twenty-one patients (51%) withdrew during the OLE; the most common primary reasons were administrative [n = 8], AEs [n = 4], and lack of efficacy [n = 3]. Thirty-five patients (85%) had ≥1 AE, 86% of which were mild or moderate in severity. Five patients (12%) reported a severe AE, none of which was considered related to study medication. The most common AEs (≥10%) were headache (27%), nausea (20%), dysmenorrhea (females; 19%), and vomiting (15%), with no relationship between AE intensity and age or dose. Five patients reported instances of suicidal ideation during the OLE, one of whom also reported this during the lead-in period. Two patients had nonsuicidal self-injurious behavior; one had a nonfatal suicide attempt. Throughout the study, there was a decrease over time in the incidence and intensity of AEs collected using the PAERS. Effectiveness assessment indicated a trend toward improvement based on numeric results. CONCLUSION: This OLE confirms the findings from the lead-in study, which concluded that a dosing strategy of 5-20 mg/day is safe, well tolerated, and suitable for future clinical studies of vortioxetine in pediatric patients.


Subject(s)
Anxiety Disorders/drug therapy , Depressive Disorder, Major/drug therapy , Vortioxetine/administration & dosage , Adolescent , Anti-Anxiety Agents/administration & dosage , Anti-Anxiety Agents/adverse effects , Anti-Anxiety Agents/pharmacokinetics , Antidepressive Agents/administration & dosage , Antidepressive Agents/adverse effects , Antidepressive Agents/pharmacokinetics , Anxiety Disorders/physiopathology , Child , Depressive Disorder, Major/physiopathology , Dose-Response Relationship, Drug , Female , Germany , Humans , Male , Prospective Studies , Psychiatric Status Rating Scales , Treatment Outcome , United States , Vortioxetine/adverse effects , Vortioxetine/pharmacokinetics
2.
J Child Adolesc Psychopharmacol ; 27(6): 526-534, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28333546

ABSTRACT

OBJECTIVE: The primary objectives of this study were to evaluate the pharmacokinetics (PK) and tolerability of single and multiple doses of vortioxetine in children and adolescents with a depressive or anxiety disorder and to provide supportive information for appropriate dosing regimens for pediatric clinical trials. METHODS: This prospective, open-label, multinational, multisite, multiple-dose trial enrolled 48 patients (children and adolescents; 1:1 ratio) divided into 8 cohorts (4 adolescent and 4 child), with each cohort including 6 patients. The cohorts in each age group were assigned to receive one of four dosing regimens: vortioxetine 5, 10, 15, or 20 mg q.d. for 14 days. The total treatment period lasted 14-20 days with patients in the higher dose cohorts uptitrated over 2-6 days. Plasma samples for PK analysis were obtained on the first and last days of dosing. RESULTS: Among children and adolescents, respectively, 62% and 92% had depression and 58% and 33% had anxiety disorder. Comorbid attention-deficit/hyperactivity disorder (ADHD) was present in 50% of children and 38% of adolescents. After 14 days q.d. at the target dose, the PK of vortioxetine concentrations was generally proportional to the dose in both age groups. Exposure, as assessed by maximum plasma concentrations and area under the plasma concentration-time curve from time 0 to 24 hours, was 30%-40% lower in adolescents than in children. There was no significant relationship between sex, height, or ADHD diagnosis and PK parameters. Most adverse events were mild in severity and consistent with those seen in adults. CONCLUSION: The results suggest that the dosages of vortioxetine evaluated (5-20 mg q.d.; approved for treatment in adults) and the uptitration schedule used are appropriate for pediatric efficacy and safety trials.


Subject(s)
Anti-Anxiety Agents/adverse effects , Anti-Anxiety Agents/pharmacokinetics , Piperazines/adverse effects , Piperazines/pharmacokinetics , Sulfides/adverse effects , Sulfides/pharmacokinetics , Adolescent , Anti-Anxiety Agents/blood , Anti-Anxiety Agents/therapeutic use , Anxiety Disorders/blood , Anxiety Disorders/drug therapy , Anxiety Disorders/epidemiology , Attention Deficit Disorder with Hyperactivity/blood , Attention Deficit Disorder with Hyperactivity/drug therapy , Attention Deficit Disorder with Hyperactivity/epidemiology , Child , Comorbidity , Depressive Disorder/blood , Depressive Disorder/drug therapy , Depressive Disorder/epidemiology , Dose-Response Relationship, Drug , Female , Humans , Male , Piperazines/blood , Piperazines/therapeutic use , Sulfides/blood , Sulfides/therapeutic use , Vortioxetine
3.
Hum Psychopharmacol ; 29(5): 470-82, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25087600

ABSTRACT

OBJECTIVE: This randomised, double-blind, 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine(10-20 mg/day) versus agomelatine (25-50 mg/day) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor (SSRI)/serotonin-noradrenaline reuptake inhibitor (SNRI) monotherapy. METHODS: Patients were switched directly from SSRI/SNRI to vortioxetine or agomelatine. Primary endpoint was change from baseline to week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score analysed by mixed model for repeated measurements, using a noninferiority test followed by a superiority test. Secondary endpoints included response and remission rates, anxiety symptoms(Hamilton Anxiety Rating Scale), Clinical Global Impression, overall functioning (Sheehan Disability Scale), health-related quality of life(EuroQol 5 Dimensions), productivity (work limitation questionnaire) and family functioning (Depression and Family Functioning Scale). RESULTS: Primary endpoint noninferiority was established and vortioxetine (n = 252) was superior to agomelatine (n = 241) by 2.2 MADRS points (p<0.01). Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12; MADRS, Hamilton Anxiety Rating Scale, Clinical Global Impression, Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards; work limitation questionnaire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12. Fewer patients withdrew because of adverse events with vortioxetine (5.9% vs 9.5%). Adverse events (incidence ≥5%) were nausea, headache, dizziness and somnolence. CONCLUSIONS: Vortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy. Vortioxetine was safe and well tolerated.


Subject(s)
Acetamides/therapeutic use , Antidepressive Agents/therapeutic use , Depressive Disorder, Major/drug therapy , Depressive Disorder, Treatment-Resistant/drug therapy , Piperazines/therapeutic use , Sulfides/therapeutic use , Acetamides/adverse effects , Adolescent , Adrenergic Uptake Inhibitors/therapeutic use , Adult , Aged , Antidepressive Agents/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged , Piperazines/adverse effects , Psychiatric Status Rating Scales , Selective Serotonin Reuptake Inhibitors/therapeutic use , Sulfides/adverse effects , Treatment Outcome , Vortioxetine , Young Adult
4.
Eur J Public Health ; 15(6): 607-12, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16126747

ABSTRACT

BACKGROUND: The objective was to test whether an association between school connectedness and smoking exists among Danish school children, and if so, to examine whether parental smoking attitude and parental smoking behaviour influenced this association. METHODS: Data were collected by the Danish contribution to the cross-national study Health Behaviour in School-Aged Children (HBSC) 1998. Analyses were performed on questionnaire-based data from 1537 students at grade nine from a random sample of schools in Denmark. RESULTS: An independent inverse association was found between school connectedness and smoking among both boys and girls. Parents' attitude to their children's smoking significantly modified this association among boys. Among girls the modifying effect was less marked. Neither among boys nor girls did parental smoking behaviour significantly modify the association between school connectedness and smoking, although a modifying tendency was observed among girls. CONCLUSIONS: The smoking behaviour of Danish adolescents may be influenced by complicated interactions of varying sets of experienced smoking norms, and any research project or preventive programme focusing on the influence of school life on adolescent smoking behaviour needs to consider the family smoking norms. Additionally, the results stress the important role of gender by indicating that the smoking behaviour of girls may be more sensitive to restricting social influences than the smoking behaviour of boys.


Subject(s)
Parent-Child Relations , Schools , Smoking/epidemiology , Adolescent , Attitude , Child , Cross-Sectional Studies , Denmark/epidemiology , Female , Humans , Male , Social Control, Informal , Surveys and Questionnaires
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