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Exercise and Olanzapine-samidorphan

Phase 4
Waitlist Available
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar disorder
  • Bipolar Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Weight

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: olanzapine-samidorphan plus exerciseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,905 Total Patients Enrolled
~20 spots leftby Apr 2027
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