Trials / Recruiting
RecruitingNCT06740890
Exercise and Olanzapine-samidorphan
A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- New York State Psychiatric Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise.
Detailed description
The principal hypothesis is that Olz/Sam combined with aerobic exercise will lead to less weight gain than Olz/Sam alone (historical data) when measured at 4 weeks. People with schizophrenia, schizoaffective and bipolar disorder I,II and NOS are eligible. After informed consent, patients will undergo a full medical/psychiatric screening and be assessed for a reason to switch antipsychotic medication. Eligible subjects will receive 8 weeks of open label Olz/Sam. Over the first 4 weeks of treatment, all subjects will complete 4 weeks of aerobic exercise for 2 to 4 days a week. Olanzapine will be flexibly dosed over the first 4 weeks according to investigator discretion. The Sam dose will remain fixed at 10 mg for the duration of the study. Subjects will undergo comprehensive weight, metabolic, and symptomatic assessments before and after 4 weeks of exercise, and again at study end (8 weeks). Cognitive assessments will be done at Visit 2/Baseline and study end. This is a single site study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olanzapine-samidorphan + exercise | 8 weeks of open label Olanzapine-samidorphan + 4 weeks of aerobic exercise |
Timeline
- Start date
- 2025-06-26
- Primary completion
- 2027-04-01
- Completion
- 2027-04-01
- First posted
- 2024-12-18
- Last updated
- 2025-07-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06740890. Inclusion in this directory is not an endorsement.