Exercise and Olanzapine-samidorphan
Part of paid clinical trials in New York, New York.
- Sponsor
- New York State Psychiatric Institute
- Study ID
- NCT06740890
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Bipolar Disorder I or II
- Bipolar Disorder NOS
- Schizoaffective Disorder
- Schizophenia Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olanzapine-samidorphan + exercise — DRUG8 weeks of open label Olanzapine-samidorphan + 4 weeks of aerobic exercise
Study Details
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.
Key Dates
- Start date
- Jun 26, 2025
- Status verified
- May 2025
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: olanzapine-samidorphan plus exercise
Primary Outcome Measure
Weight [ Time Frame: 4 weeks ]
Central Contacts
- Megan Mayer, BA646-774-8477
- Joshua T Kantrowitz, MD646-774-6738
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 |
Find similar trials in New York, NY
By condition
By specialty
By research site
Related Studies
- Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical TrialPHASE4 · Recruiting · New York State Psychiatric Institute · Los Angeles, California
- Effectiveness of Motivation Skills Training (MST)Recruiting · Columbia University · New York, New York
- Biomarkers to Enhance Early Schizophrenia TreatmentPHASE4 · Recruiting · Northwell Health · La Jolla, California
- Database Registry for Neural Network Biomarkers in PsychosisRecruiting · University of Texas Southwestern Medical Center · Dallas, Texas