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Completed NCT07834112

Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder: a Multicenter Retrospective Study of Selected Follow-up Cohort

Conditions: Bipolar Disorder (BD)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 155
Sponsor: Dong-Wook Kim

Location: Garam Mental Health Clinic Seoul

Summary

Study Objective: To evaluate the treatment effectiveness and safety by analyzing prescription patterns in a routine clinical practice setting and observing changes in clinical indicators (weight, BMI, HAM-D, CGI-S, CGI-I) among patients prescribed Lurasidone for the treatment of bipolar disorder. Study Design: Retrospective, Multi-center, Investigator-Initiated Observational Study.

Eligibility Criteria

Inclusion Criteria: 1. Adults aged 18 to 65 years 2. Confirmed diagnosis of bipolar disorder 3. Minimum 8-week stable treatment on atypical antipsychotics (Aripiprazole, Olanzapine, Quetiapine) followed by a switch to Lurasidone due to metabolic side effects (weight gain). 4. Completed 16-week follow-up post-switch Exclusion Criteria: 1. Pregnant or lactating women 2. Subjects for whom administration of lurasidone is contraindicated according to the approved labeling 3. Subjects who discontinued lurasidone or switched to another medication within 8 weeks of the initial switch to lurasidone 4. Subjects for whom data on body weight, height, HAM-D, CGI-S, or CGI-I were not collected at least once across all visits 5. Subjects judged by the investigator to be ineligible for participation in the study for other reasons

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07834112). StuddyBuddy aggregates publicly available trial information.