Exercise and Olanzapine-samidorphan
Recruiting
Phase 4
Interventional Study
Schizophenia Disorder
Schizoaffective Disorder
Bipolar Disorder I or II
Bipolar Disorder NOS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- New York State Psychiatric Institute · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age between 18-65, inclusive at Visit 1.
2. DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I/II/NOS disorder at Visit 1.
3. Body Mass Index (BMI) of 18.0-40.0 kg/m2, inclusive, at Visits 1 and 2.
4. Willing to provide informed consent at Visit 1.
5. Medically …
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