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NCT07834112

Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder

StatusCompleted
PhaseNot specified
Primary completion
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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 ↗

  1. Minor Secondary endpoints: 10 to 11
    • Study title shortened, about 8 words
  2. 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