NCT07834112
Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder
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Record History
All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Minor Secondary endpoints: 10 to 11
- Study title shortened, about 8 words
- Study First Submitted
- Minor: routine updates
Endpoints
Primary
Change in body weight from baseline to 16 weeks
Timeframe: 16 weeks
Secondary (11)
Change in body weight from baseline to 4 weeks
Change in rate of weight change
Change in body weight according to prior medication
Change in BMI
Change in HAM-D scores
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Change in scores for each HAM-D item
Change in CGI-S scores
Mean values and changes in CGI-I scores
Antipsychotic equivalent doses
Change in body weight according to Lurasidone dosage
Change in body weight in subjects with concomitant use of antipsychotics
Arms and interventions
Bipolar Disorder Patients Switched to Lurasidone
Patients diagnosed with bipolar disorder who had been stably treated with atypical antipsychotics (aripiprazole, olanzapine, or quetiapine) for at least 8 weeks, subsequently switched to lurasidone due to metabolic side effects (weight gain), and completed a 16-week follow-up period post-switch.
Drugs: Lurasidone
Sites
1 site in 1 country
- Garam Mental Health ClinicSeoul, South Korea