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.
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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 …
Contacts

Megan Mayer, BA

646-774-8477

megan.mayer@nyspi.columbia.edu

CONTACT

Joshua T Kantrowitz, MD

646-774-6738

joshua.kantrowitz@nyspi.columbia.edu

CONTACT