NCT07834112Completed
Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder
A Retrospective Observational Study on Weight Change, Effectiveness, and Safety Following Switching to Lurasidone in Korean Patients With Bipolar Disorder Under Routine Clinical Practice
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 155 (actual)
- First submitted
- 16 Sept 2026
- Start date
- 9 Sept 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Dong-Wook Kim
- Diseases
- Bipolar disorder
- NCT number
- NCT07834112
What you commit to
- Study type: Observational
- Participants enrolled: 155
- From 9 Sept 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who discontinued lurasidone or switched to another medication within 8 weeks of the initial switch to lurasidone
Other
- Pregnant or lactating women
- Subjects for whom administration of lurasidone is contraindicated according to the approved labeling
- Subjects for whom data on body weight, height, HAM-D, CGI-S, or CGI-I were not collected at least once across all visits
- Subjects judged by the investigator to be ineligible for participation in the study for other reasons
Who the study is looking for
- Adults aged 18 to 65 years
- Confirmed diagnosis of bipolar disorder
- Minimum 8-week stable treatment on atypical antipsychotics (Aripiprazole, Olanzapine, Quetiapine) followed by a switch to Lurasidone due to metabolic side effects (weight gain).
- Completed 16-week follow-up post-switch
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Garam Mental Health Clinic Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.