Lamotrigine as an adjuvant treatment for acute bipolar depression: a Brazilian naturalistic study

Lamotrigine is indicated according to several recent treatment guidelines as a first-line medication for the treatment of bipolar depression. However, its efficacy in acute bipolar depression has not been well established. In the present naturalistic study, patients with bipolar depression (n = 20), predominantly bipolar type I, were treated with lamotrigine in addition to their prior treatment for 8 weeks. The Young Mania Rating Scale (YMRS), 17-item Hamilton Rating Scale for Depression (HAM-D-17), and Clinical Global Impressions-Bipolar Disorder (CGI-BD) scale were applied at baseline, week 4, and week 8. With regard to the primary measure of efficacy, mean total HAM-D-17 scores significantly decreased (p < .01) at the end of treatment. Eight patients (40%) exhibited a positive response (i.e., at least a 50% reduction of baseline scores). Additionally, eight (40%) and 11 (55%) patients exhibited complete remission, reflected by HAM-D-17 and CGI-BP scores, respectively. Episodes of switching to mania or hypomania occurred in five patients (25%). No skin rash or any other significant adverse events were reported. Our results indicate that the addition of lamotrigine to a mood stabilizer can be useful in the treatment of acute depressive episodes in bipolar I disorder.

Major Depression: A Short Term Naturalistic Study in Outpatients.

Background: Surprisingly data regarding naturalistic or observational studies carried out in India to study Major Depressive Disorder in patients seeking outpatient treatment is almost non-existing. So this study was conducted to study the presentation and baseline characteristics of Major Depressive Disorder in Indian outpatients and the subsequent treatment and outcome after a three month follow up. Methodology: Patients seeking outpatient treatment were recruited after diagnosing an episode of Major Depressive Disorder through a clinical interview for DSM IV TR. Sociodemographic and clinical characteristics were recorded at the time of recruitment and follow up evaluations done for 3 months. All the patients were given outpatient treatment best suited to the patient profile. Results :.More than 90% patients reported one or more somatic symptoms spontaneously on presentation . Barely half of the patients out of 119 recruited completed three month follow up. 50 (81%) patients out of 62 who received adequate treatment met recovery criteria at the end of three months. Initial depression severity and receiving regular adequate antidepressant therapy was found to be associated with recovery. While sociodemographic variables were not found to significantly affect treatment outcome or compliance. Conclusion : Somatic presentation of depression is quite common in Indian patients .The high noncompliance indicate the need for strategies to be made to improve compliance and the good response to treatment found in naturalistic conditions in this study calls for more such studies to be done for better understanding of predictors of outcome in naturalistic conditions in India.

Antipsychotic Effects of Quetiapine in Naturalistic Long Term Follow Up Study

OBJECTIVE: This study aimed to examine the effectiveness of quetiapine and the effects of dosage relates to its effectiveness on schizophrenia and schizoaffective disorder in a naturalistic setting in Korean people. METHODS: This study was a 24-week, open-label, non-comparative, naturalistic study of quetiapine in patients diagnosed with schizophrenia and schizoaffective disorder according to DSM-IV. We stratified the patients into mild [(clinical global impression severity (CGI-S) or =4 at baseline). We investigated the response rate, defined as clinical global impression improvement (CGI-I) < or =2, in the severe group and the aggravation rate in the mild group using the last-observation-carried-forward (LOCF) and the Kaplan-Meier method (K-M). RESULTS: During the 24 weeks, 151 (18.4%) of the participants dropped out of the study. There was a significant decrease in the mean CGI-S score, from 4.5+/-1.1 at baseline to 2.8+/-1.1 at 24 weeks. The response rate of severe group was 54.5% (estimated by LOCF) and 73.3% (K-M estimated) at 24 weeks. All patients who completed the study had taken a mean quetiapine dosage of 507.9+/-245.9 mg daily. The decrease of CGI-S score in high-dose group (the maximum dose was 750 mg/d or above) was statistically significant than that in recommended-dose group (the maximum dose was less than 750 mg/d). CONCLUSION: This study demonstrated the long-term effectiveness of quetiapine in the treatment of schizophrenia and schizoaffective disorder in a naturalistic setting in Korean people. This study suggests that higher than recommended quetiapine dosages could be more effective in some patients.

Effectiveness of Lamotrigine Adjunctive Treatment of Depressive Symptoms in Patients with Bipolar Disorder Not Otherwise Specified: A 52-Week Prospective Naturalistic Study / 대한정신약물학회지

OBJECTIVE: The pharmacotherapy of bipolar disorder not otherwise specified (BP-NOS) has been insufficiently studied. The aim of this prospective naturalistic study was to explore the effectiveness of lamotrigine adjunctive treatment in patients with BP-NOS. METHODS: Data from 50 patients diagnosed with BP-NOS were analyzed. On the basis of the prospective mood chart methodology, the efficacy of lamotrigine adjunctive treatment was assessed by changes in the mean Clinical Global Impressions-Bipolar Version (CGI-BP) depression scores. A paired t-test was used to test the statistical significance of the changes in CGI-BP depression scores. Repeated-measures analysis of variance (RM ANOVA) with simple effect analysis was performed to explore the sequential changes during a 52-week period. Cohen's d was calculated to measure the magnitude of the treatment effects on the changes in depression severity. Time to lamotrigine discontinuation was also calculated using the Kaplan-Meier estimates. Lamotrigine-associated adverse events were monitored every two weeks. RESULTS: A significant decrease, with a large effect size (Cohen's d=1.6), in the mean CGI-BP depression scores was associated with lamotrigine adjunctive treatment in intent-to-treat analysis (t=8.7, df=49, p<0.001). Twenty-four patients (48.0%) completed 52-week lamotrigine adjunctive treatment. Analysis of the data obtained from those completing the treatment revealed a large effect (Cohen's d=4.0) on improvement in the severity of depression (t=16.8, df=32, p<0.001). Sixty percent of patients achieved remission (n=30), and 64% of patients (n=32) showed some clinical response to lamotrigine adjunctive treatment. The mean time to lamotrigine discontinuation was 31.3+/-3.1 weeks (CI=25.2-37.4). Lamotrigine adjunctive treatment was well tolerated, with no serious rashes reported. CONCLUSION: Lamotrigine seems to be effective in the management of depressive symptoms in BP-NOS. Long-term use of lamotrigine was generally safe and well tolerated. Large-scale controlled trials might be needed to confirm the findings of this naturalistic study.

The Variations in the Treatment Pattern of Schizophrenic Patients with Risperidone and Olanzapine / 신경정신의학

OBJECTIVES: Considerable variations in the contents of clinical practice are the natural consequences of the fact that so many factors can have influences on each clinical decision making processes in the psychiatric treatment, let alone the pharmacotherapy of schizophrenia. To attain the goal of rational treatment, it is needed to examine the actual contents of clinical practices and the degree of variations among diverse hospitals. In addition, it is also needed to look into the unique situations in which each hospital is situated. For this purpose, this study tried to investigate the degree of variations in several aspects of the treatment of schizophrenia with atypical antipsychotics currently practiced in Korea. METHODS: This study is based on the data from RODOS (Risperidone Olanzapine Drug Outcome Study) in Korea. This study had been designed as a multi-center naturalistic study, therefore, had many advantages for the survey study of actual clinical practices. The subjects of the study were the in-patients who had been given risperidone or olanzapine for the control of their psychotic symptoms. Clinical data had been gathered by retrospective chart review. The degree and the characteristics of the variations were examined by comparing the patient-characteristic variables and the treatment-related variables among each hospital. RESULTS: The differences in the baseline characteristics of the patients including the duration of illness and the past history of psychiatric treatment were substantial among each hospital, and these differences seemed to explain a great portion of the variations in the contents of treatment. The variations in the dosage of risperidone and olanzapine were not conspicuous among each hospital. However, the variations in other treatment-related variables, including duration of admission, proportion of combined therapy with other antipsychotics, usage of anticholinergics, detection rate of extrapyramidal symptoms, remained statistically significant after adjusting the baseline patient characteristics as covariates. Although no significant correlation among each variable was found, a couple of unique practice patterns common to several hospitals could be observed. CONCLUSIONS: Considerable variations in the diverse treatment-related variables were observed in the treatment of schizophrenic patients with risperidone and olanzapine. It seemed that the major portion of these variations could be explained by the characteristic of patient group. However, the possibility remained that the other factors including the socio-cultural environment of the community and the disposition of the clinician themselves were still the major contributing factors to these variations. It is expected that the future clinical practice surveys like this study can help the clinicians to reevaluate their current practices, and can help to accumulate the basic data needed to establish the more rational and customized treatment practices.

A 2-Year Naturalistic Study on Trends in Pharmacotherapy and Change of Clinical Symptoms in the Patients with Obsessive-Compulsive Disorder / 대한정신약물학회지

OBJECTIVE: The purpose of this study was to examine the pharmacological treatment patterns and clinical responses in inpatients and/or outpatients with obsessive compulsive disorder (OCD) at a university hospital. METHODS: A total of 71 OCD patients were included and followed during the first 4 months, first year and second year from 1998. The patterns of medication use and clinical responses according to the Yale-Brown obsessive-compulsive scale (Y-BOCS) were analyzed descriptively in this period. RESULTS: During the first 4 months, 26.7% of the patients underwent monotherapy in which most of the drugs were serotonin reuptake inhibitors (SRIs). Therapy with two or more drugs was administered in 66.6% of the patients and combination drugs with SRIs were atypical antipsychotics and clonazepam. The clinical response rate using Y-BOCS was 24.0% compared with baseline score. During the first year, the frequency of the monotherapy decreased to 6.5%, while that of therapy with two or more drugs increased to 80.6% (two and three drug frequencies were 35.3%, and 32.3%, respectively). The clinical response rate was 26.4% during this period. During the second year, the frequency of the monotherapy was 25% and that of multidrug therapy was 70.8% (two and three drug frequencies were 20.8%, and 45.8%, respectively). The clinical response rate was 39.3% compared with baseline score. CONCLUSIONS: In this study, the frequency of the combination therapy was relatively high compared with SRI monotherapy during the first 4 months and it increased further during the first year. The combination therapy was maintained without change of SRI dosage during the second year. Most of the drugs used in the combination therapy were atypical antipsychotics and clonazepam.

Trends in Pharmacotherapy of the Hospitalized Patients with Bipolar Disorder: A Twele-year Naturalistic Study / 대한정신약물학회지

OBJECTIVE: The purpose of this study was to examine the pharmacological treatment patterns in inpatients with bipolar disorder at a university hospital, and to establish appropriate clinical practice guideline in light of recent advances of pharmacotherapy of bipolar disorder. METHODS: A total of 454 first-admission cases with a diagnosis of bipolar disorder or schizoaffective disorder from 1990 to 2001 were analyzed with regard to the clinical characteristics and the use of mood stabilizers, antidepressants and antipsychotics. RESULTS: In manic, hypomanic, and mixed episodes, there has been a substantial increase in the use of valproate while the use of lithium has decreased. Antipsychotic drugs were prescribed as combination regimen in over 80% of total cases. In 44.6% of bipolar depression cases, mood stabilizers were not prescribed. In 70.7% of bipolar depression cases not receiving mood stabilizers, antidepressant monotherapy was utilized. The use of SSRIs and RIMA has increased, while a decrease was observed for TCA. There has been a tendency of the increased use of atypical antipsychotics. In particular, clozapine monotherapy has increased in mood stabilizer resistant cases. CONCLUSIONS: The results of the present study suggest that the prescription patterns have changed in general agreement with recent advances of pharmacotherapy of bipolar disorder during the past twelve years. However, there was clear tendency to use antipsychotics rather than other mood stabilizers as the combination regimen. Moreover, accurate diagnosis and careful reconsideration for pharmacological treatment strategies are required in bipolar depression, mixed states, and rapid cycling.

A Naturalistic Study of Atypical Antipsychotic Use in Inpatients with Bipolar I Disorder / 신경정신의학

OBJECTIVES: This study was conducted to evaluate the prescription patterns, overall efficacy, and safety of atypical antipsychotics for inpatients with bipolar I disorder. METHODS: Inpatients with bipolar I disorder, who had received adjunctive treatment with olanzapine or risperidone, beyond 1 month, along with mood stabilizers were selected for a retrospective study. The charts of those patients(N=56) were reviewed for the details of efficacy, safety, and other pharmacological variables of the two drugs. RESULTS: Olanzapine and risperidone showed equivalent efficacy by the evaluation in accordance with clinical global impression scale (CGI) and global assessment of functioning scale(GAF) score. Different side effect profiles were noted between two drugs. CONCLUSION: These limited results suggested that the efficacy and safety of risperidone and olanzapine were similar for the treatment of inpatients with bipolar I disorder. Prospective controlled study for efficacy and safety of risperidone and olanzapine in the treatment of bipolar I disorder should be conducted in future.

Comparison of Risperidone and Olanzapine Use in the Treatment of Inpatients with Schizophrenia / 대한정신약물학회지

OBJECTIVE: This retrospective study was designed to compare the drug usage patterns and clinical outcomes of patients who received either risperidone or olanzapine in a naturalistic setting at a university hospital. METHODS: Inpatients with schizophrenia given either risperidone or olanzapine, as a single oral antipsychotic drug during hospitalization were retrospectively investigated. Data on patients' age, sex, efficacy, duration of hospitalization, dosage, use of antiparkisonian drugs, cost of drugs, weight changes, and hepatotoxicity were collected. RESULTS: Sixty patients, 30 patients for each group, were evaluated. No significant differences were observed between groups for age, sex, the duration of hospitalization, the degree to the improvement of Global Assessment of Functioning and weight gain. The mean daily antiparkinsonian medication use expressed in benztropine equivalents was significantly lower (p<0.001) in the olanzapine group (0.8 mg+/-0.9) than in the risperidone group (2.2 mg+/-0.8). For risperidone, the mean daily dose and associated cost at discharge were 5.6 (+/-1.1)mg and 765.6 (+/-144.9) won per day, whereas those for olanzapine were 15.8 (+/-4.0)mg and 1884.2 (+/-470.9) won per day (p<0.001). A mild increase of liver enzymes was found in both groups. CONCLUSION: It appears from this study that both risperidone and olanzapine are relatively safe and effective in inpatients with schizophrenia. While olanzapine group shows a superior profile in the neurological side effects, risperidone group exhibits better profile in the daily cost of drug. Further controlled studies are recommended to confirm these findings.