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Exercise and Olanzapine-samidorphan

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Start date changed from estimate of Jun 15, 2025 to Jun 26, 2025v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2025 to Jun 15, 2025
    • Site details revised
    v4
  4. Start date: Apr 2025 to May 2025v3
  5. Study description revisedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06740890
Lead Sponsor New York State Psychiatric Institute
Conditions
(from sponsor)		 Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder I or II, Bipolar Disorder NOS
Related terms Bipolar Disorder, Motor Activity, Psychotic Disorders
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov