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

Dong-Wook Kim155 enrolled

Overview

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.

This study is a retrospective, multi-center, observational study. Based on the Institutional Review Board (IRB) approval date, patients will be registered who had been stably taking atypical antipsychotics (Aripiprazole, Olanzapine, Quetiapine) for more than 8 weeks during the past period for the treatment of bipolar disorder, but changed the medication to Lurasidone due to metabolic side effects (weight gain) (patients followed up for 16 weeks). Clinical effectiveness and safety information, such as adverse events, will be collected through body weight and questionnaires (HAM-D, CGI-S, CGI-I) before and after switching Lurasidone.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Bipolar Disorder (BD)

Interventions

LurasidoneDRUG

Lurasidone Hydrochloride 20mg/40mg/60mg/80mg/120mg, with patients followed up for 16 weeks after switching to Lurasidone Hydrochloride.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Garam Mental Health Clinic

Seoul, South Korea

Outcomes

Primary Outcomes

Change in body weight from baseline to 16 weeks

Change in body weight from baseline to 16 weeks after Lurasidone prescription in the total population

Time frame: 16 weeks

Secondary Outcomes

Change in body weight and rate of weight change

Change in body weight from baseline to 4 weeks, and the rate of weight change during 4 weeks and 16 weeks after Lurasidone prescription in the total population