Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID06740890

A Proof of Concept Study of Time Limited Exercise Plus Olanzapine-samidorphan for the Prevention of Early Weight Gain

Led by New York State Psychiatric Institute · Updated on 2025-07-11

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults aged 18 to 65 with schizophrenia, schizoaffective disorder, or bipolar disorder types I, II, or NOS. This trial aims to determine if combining the drug olanzapine-samidorphan with aerobic exercise reduces early weight gain compared to historical data on the drug alone. The study is a Phase 4, single-site trial focusing on weight and metabolic effects. Participants will receive open-label olanzapine-samidorphan for eight weeks. During the first four weeks, they will also engage in aerobic exercise two to four times weekly. Olanzapine dosing is flexible and adjusted by the study doctor, while the samidorphan dose remains fixed at 10 mg throughout the study. Before starting, participants undergo medical and psychiatric screening. Weight, metabolic health, and symptoms are assessed before and after the exercise period and again at the study's end (eight weeks). Cognitive tests happen at baseline and study completion. The research team monitors changes in weight at four weeks as the main outcome, with additional assessments continuing through eight weeks.

CONDITIONS

Brief Title

Exercise and Olanzapine-samidorphan

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years at first visit
  • Diagnosis of schizophrenia, schizoaffective disorder, or Bipolar I, II, or NOS disorder
  • Body Mass Index between 18.0 and 40.0 kg/m2 at Visits 1 and 2
  • Willing and able to provide informed consent
  • Medically and psychiatrically stable for participation
  • Responsive to antipsychotic treatment (other than clozapine) in the past 5 years
  • Has a reason to participate, such as inadequate efficacy or side effects on current treatment, or desire to try olanzapine-samidorphan or exercise
  • Stable body weight (less than 5% change) for at least 3 months prior to first visit
  • Willing to use qualified contraception methods if of childbearing potential (women only)
Not Eligible

You will not qualify if you...

  • Positive drug screen for opioids, phencyclidine, amphetamines, or cocaine at Visits 1 or 2
  • Moderate or severe substance use disorder or clinically significant eating disorder
  • Clinically significant EKG abnormalities including prolonged QT interval
  • Use of olanzapine-samidorphan in past 6 months or poor response history to olanzapine
  • Use or anticipated need for opioid agonists or antagonists recently or during study
  • Pregnant or breastfeeding women; must have negative pregnancy tests
  • Clinically significant or unstable medical illnesses affecting safety or study results
  • History of significant neurological conditions or events within past year
  • Significant cardiac conditions or recent heart issues
  • Use of contraindicated medications per olanzapine-samidorphan labeling
  • Suicidal ideation with intent or plan recently or currently
  • Inflammatory bowel disease or gastrointestinal disorders causing weight loss
  • Recent or planned participation in weight management or significant diet/exercise changes
  • History of diabetes
  • Laboratory abnormalities compromising well-being or specific abnormal lab results
  • Considered unfit for trial by investigator at Visits 1 and 2

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive 8 weeks of open label Olanzapine-samidorphan medication. During the first 4 weeks, they complete aerobic exercise sessions 2 to 4 days per week.

Weekly visits for up to 8 weeks

Trial Site Locations

Total: 1 location

1

New York State Psychiatric Institute

New York, New York, United States, 10032

Actively Recruiting

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Research Team

M

Megan Mayer, BA

J

Joshua T Kantrowitz, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis.

Maximilian Huhn, Adriani Nikolakopoulou, Johannes Schneider-Thoma...

https://pubmed.ncbi.nlm.nih.gov/31303314

Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study.

Christoph U Correll, John W Newcomer, Bernard Silverman...

https://pubmed.ncbi.nlm.nih.gov/32791894