Bipolar Disorder (BD)NCT07834112
Body Weight Changes After Switching to Lurasidone for Antipsychotic-induced Weight Gain in Bipolar Disorder
An observational study of Bipolar Disorder (BD), run by Dong-Wook Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Lurasidone
- How many people
- 155 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with bipolar disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Lurasidone
- Keywords
- bipolar disorder, overweight, Korean
- Medical subject headings
- Bipolar Disorder, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Lurasidone Hydrochloride 20mg/40mg/60mg/80mg/120mg, with patients followed up for 16 weeks after switching to Lurasidone Hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (11)
Change in body weight from baseline to 4 weeks
Change in body weight from baseline to 4 weeks after Lurasidone prescription in the total population
Measured: 4 weeks
Change in rate of weight change
Change in rate of weight change during 4 weeks and 16 weeks after Lurasidone prescription in the total population
Measured: 4 weeks and 16 weeks
Change in body weight according to prior medication
Change in body weight from baseline to 4 weeks and 16 weeks after Lurasidone prescription according to prior medication
Measured: 4 weeks and 16 weeks
Change in BMI
Change in BMI from baseline to 4 weeks and 16 weeks after Lurasidone prescription in the total population
Measured: 4 weeks and 16 weeks
Change in HAM-D scores
Change in scores on the 17-item Hamilton Depression Rating Scale(HAM-D), ranging from 0 to 52, from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population. Higher scores indicate greater severity of depressive symptoms.
Measured: 4 weeks and 16 weeks
Change in scores for each HAM-D item
Change in scores for each item of the 17-item Hamilton Depression Rating Scale (HAM-D) from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population. The score range is 0-4 for most items and 0-2 for items with a maximum score of 2. Higher scores indicate greater severity of depressive symptoms.
Measured: 4 weeks and 16 weeks
Change in CGI-S scores
Change in scores on the Clinical Global Impression-Severity of Illness (CGI-S) scale from baseline to 4 weeks and 16 weeks of Lurasidone prescription in the total population. The score ranges from 1 to 7, with higher scores indicating greater severity of illness.
Measured: 4 weeks and 16 weeks
Mean values and changes in CGI-I scores
Mean values and changes in scores on the Clinical Global Impression-Improvement (CGI-I) scale at 4 weeks and 16 weeks of Lurasidone prescription in the total population. The score ranges from 1 to 7, with lower scores indicating greater improvement and higher scores indicating worsening of illness.
Measured: 4 weeks and 16 weeks
Antipsychotic equivalent doses
Analysis of antipsychotic equivalent doses (Defined Daily Dose ratio) before and after medication switch
Measured: Before and after medication switch
Change in body weight according to Lurasidone dosage
Change in body weight according to Lurasidone dosage
Measured: 16 weeks
Change in body weight in subjects with concomitant use of antipsychotics
Change in body weight in subjects with concomitant use of antipsychotics (Second-generation antipsychotics, SGA)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start9 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-Wook Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Responsible party
- Sponsor-investigator, Dong-Wook Kim, Garam Mental Health Clinic
- Investigators
- Dong-Wook Kim, M.D., Study chair, Garam Mental Health Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834112
- Sponsor's protocol ID
- BK-LUD-I01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07834112
- Acronym / sponsor ID
- BK-LUD-I01
- Conditions
- Bipolar Disorder (BD)
- Keywords
- bipolar disorder, overweight, Korean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Dong-Wook KimUniversity, hospital or other
- Collaborators
- Bukwang Pharmaceutical, Co., Ltd.
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder Patients Switched to Lurasidone | – | Drug: LurasidonePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with bipolar disorder
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneLurasidone Hydrochloride 20mg/40mg/60mg/80mg/120mg, with patients followed up for 16 weeks after switching to Lurasidone Hydrochloride. | Drug | Bipolar Disorder Patients Switched to Lurasidone |
Primary outcome
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
11 secondary outcomes
Change in body weight from baseline to 4 weeks
Time frame: 4 weeks
Change in rate of weight change
Time frame: 4 weeks and 16 weeks
Change in body weight according to prior medication
Time frame: 4 weeks and 16 weeks
Change in BMI
Time frame: 4 weeks and 16 weeks
Change in HAM-D scores
Time frame: 4 weeks and 16 weeks
Change in scores for each HAM-D item
Time frame: 4 weeks and 16 weeks
Change in CGI-S scores
Time frame: 4 weeks and 16 weeks
Mean values and changes in CGI-I scores
Time frame: 4 weeks and 16 weeks
Antipsychotic equivalent doses
Time frame: Before and after medication switch
Change in body weight according to Lurasidone dosage
Time frame: 16 weeks
Change in body weight in subjects with concomitant use of antipsychotics
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Wook Kim, M.D. study chair
Garam Mental Health Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder (BD), run by Dong-Wook Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from baseline to 16 weeks (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.