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Exercise and Olanzapine-samidorphan

NCT06740890 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

  • Schizophenia Disorder
  • Schizoaffective Disorder
  • Bipolar Disorder I or II
  • Bipolar Disorder NOS

Interventions

DRUG

Olanzapine-samidorphan + exercise

8 weeks of open label Olanzapine-samidorphan + 4 weeks of aerobic exercise

Sponsors & Collaborators

  • New York State Psychiatric Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740890 on ClinicalTrials.gov