Exercise and Olanzapine-samidorphan

NCT06740890 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024-2028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exercise; Antipsychotic induced weight gain; olanzapine-samidorphan

Outcome Measures

Primary Outcomes (1)

• Weight

  Body weight

  4 weeks

Secondary Outcomes (1)

• Weight

  8 weeks

Study Arms (1)

olanzapine-samidorphan plus exercise

EXPERIMENTAL

Drug: Olanzapine-samidorphan + exercise

Interventions

Olanzapine-samidorphan + exercise DRUG

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

olanzapine-samidorphan plus exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65, inclusive at Visit 1.
• DSM-V diagnosis of schizophrenia or schizoaffective or Bipolar I/II/NOS disorder at Visit 1.
• Body Mass Index (BMI) of 18.0-40.0 kg/m2, inclusive, at Visits 1 and 2.
• Willing to provide informed consent at Visit 1.
• Medically and psychiatrically stable for study participation at Visit 1.
• Responsive to an antipsychotic treatment (other than clozapine) in the past 5 years prior to Visit 1.
• Can benefit from participation in this study and has a reason to participate, such as inadequate efficacy on current treatment, side effects on current treatment, desire to start olanzapine-samidorphan or try structured exercise program (assessed at Visit 1).
• Maintained a stable body weight (change \< 5%) for at least 3 months prior to Visit 1.
• Willing to use qualified methods of contraception (listed in section 5.3) for the study duration (for women of childbearing potential only) (assessed at Visit 1 and Visit 2).

You may not qualify if:

• Positive drug screen for opioids, phencyclidine, amphetamine/ methamphetamine, or cocaine at Visit 1 or Visit 2.
• Diagnosis of moderate or severe substance use disorder, anorexia nervosa, bulimia, binge eating disorder or any other clinically significant eating disorder at Visit 1.
• EKG abnormality that is clinically significant including a QT interval \> 450 msec for men and \> 470 msec for women, as corrected by the Fridericia formula (QTcF) at Visit 1.
• Use of olanzapine+samidorphan for any reason in the last six months prior to Visit 1, any history of poor or inadequate response to treatment with olanzapine or no justifiable reason to expect improvement on olanzapine as assessed at Visit 1.
• Taken opioid agonists (e.g., codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period (e.g., planned surgery), or has taken opioid antagonists including naltrexone (any formulations) or naloxone within 60 days prior to Visit 1.
• Pregnant or breast feeding women. Women of child-bearing potential must have a negative serum beta-hCG pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2.
• Any clinically significant or unstable medical illness, condition, or disorder that is anticipated to potentially compromise subject safety on study medication or exercise, or adversely affect the evaluation of efficacy, including (but not necessarily limited to) the following (as assessed at Visit 1):
• Clinically significant hypotension or hypertension not stabilized on medical therapy.
• Unstable thyroid dysfunction in the past 6 months (e.g., hypothyroidism, hyperthyroidism, or thyroiditis that was untreated, or discovered and treatment was initiated within the 6 months prior to screening).
• Personal or family history of neuroleptic malignant syndrome, has a history of clinically significant extrapyramidal symptoms when taking olanzapine, or has had clinically significant tardive dyskinesia.
• Neurological conditions include the following:
• History of seizure disorder or a condition associated with seizures (except history of febrile seizures).
• History of brain tumor, subdural hematoma, stroke or any other clinically significant neurological condition within the 12 months prior to Visit 1.
• Head trauma with loss of consciousness within the 12 months prior to Visit 1.
• Active, acute or chronic CNS infection.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

RECRUITING

Related Publications (2)

• Huhn M, Nikolakopoulou A, Schneider-Thoma J, Krause M, Samara M, Peter N, Arndt T, Backers L, Rothe P, Cipriani A, Davis J, Salanti G, Leucht S. 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. Lancet. 2019 Sep 14;394(10202):939-951. doi: 10.1016/S0140-6736(19)31135-3. Epub 2019 Jul 11.

  PMID: 31303314 BACKGROUND

• Correll CU, Newcomer JW, Silverman B, DiPetrillo L, Graham C, Jiang Y, Du Y, Simmons A, Hopkinson C, McDonnell D, Kahn RS. Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study. Am J Psychiatry. 2020 Dec 1;177(12):1168-1178. doi: 10.1176/appi.ajp.2020.19121279. Epub 2020 Aug 14.

  PMID: 32791894 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Megan Mayer, BA

CONTACT

646-774-8477; megan.mayer@nyspi.columbia.edu

Joshua T Kantrowitz, MD

CONTACT

646-774-6738; joshua.kantrowitz@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: six months after publication
• Access Criteria: upon request

Locations

US (1)