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Completed

NCT Number: 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

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.

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Key information

Conditions

Bipolar Disorder (BD) Bipolar Disorder Bipolar and Related Disorders Body Weight Mental Disorders Mood Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Garam Mental Health Clinic

Seoul, 08768, South Korea

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lurasidone

Drug

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

Primary outcomes

  1. Change in body weight from baseline to 16 weeks

    Time frame: 16 weeks

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

Secondary outcomes

  1. Change in body weight and rate of weight change

    Time frame: 4 weeks and 16 weeks

    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

  2. Change in body weight according to prior medication

    Time frame: 4 weeks and 16 weeks

    Change in body weight from baseline to 4 weeks and 16 weeks after Lurasidone prescription according to prior medication

  3. Change in BMI

    Time frame: 4 weeks and 16 weeks

    Change in BMI from baseline to 4 weeks and 16 weeks after Lurasidone prescription in the total population

  4. Change in HAM-D scores

    Time frame: 4 weeks and 16 weeks

    Change in HAM-D scores from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population

  5. Change in scores for each HAM-D item

    Time frame: 4 weeks and 16 weeks

    Change in scores for each HAM-D item from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population

  6. Change in CGI-S scores

    Time frame: 4 weeks and 16 weeks

    Change in CGI-S scores from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population

  7. Mean values and changes in CGI-I scores

    Time frame: 4 weeks and 16 weeks

    Mean values and changes in CGI-I scores at 4 weeks and 16 weeks of Lurasidone prescription in the total population

  8. Antipsychotic equivalent doses

    Time frame: Before and after medication switch

    Analysis of antipsychotic equivalent doses (Defined Daily Dose ratio) before and after medication switch

  9. Change in body weight according to Lurasidone dosage

    Time frame: 16 weeks

    Change in body weight according to Lurasidone dosage

  10. Change in body weight in subjects with concomitant use of antipsychotics

    Time frame: 16 weeks

    Change in body weight in subjects with concomitant use of antipsychotics (Second-generation antipsychotics, SGA)

Sponsors and collaborators

Lead sponsor

Dong-Wook Kim

Other

Collaborators

  • Bukwang Pharmaceutical, Co., Ltd.

Registry information

Official study title

A Retrospective Observational Study on Weight Change, Effectiveness, and Safety Following Switching to Lurasidone in Korean Patients With Bipolar Disorder Under Routine Clinical Practice

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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