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

NCT07834112 | Completed

• 1 other identifier: BK-LUD-I01
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder (BD)

Keywords

bipolar disorder; overweight; Korean

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (11)

• Change in body weight from baseline to 4 weeks

  4 weeks

• Change in rate of weight change

  4 weeks and 16 weeks

• Change in body weight according to prior medication

  4 weeks and 16 weeks

• Change in BMI

  4 weeks and 16 weeks

• Change in HAM-D scores

  4 weeks and 16 weeks

Study Arms (1)

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.

Drug: Lurasidone

Interventions

Lurasidone DRUG

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

Bipolar Disorder Patients Switched to Lurasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with bipolar disorder

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating women
• Subjects for whom administration of lurasidone is contraindicated according to the approved labeling
• Subjects who discontinued lurasidone or switched to another medication within 8 weeks of the initial switch to lurasidone
• 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

Sponsors & Collaborators

• Dong-Wook Kim: lead
• Bukwang Pharmaceutical, Co., Ltd.: collaborator

Study Sites (1)

Garam Mental Health Clinic

Seoul, 08768, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder; Overweight

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong-Wook Kim, M.D.

  Garam Mental Health Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 9, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)