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