Health TrialsbyHealthPanel

Exercise and Olanzapine-samidorphan

ConditionsSchizophenia DisorderSchizoaffective DisorderBipolar Disorder I or IIBipolar Disorder NOS
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNew York State Psychiatric Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Olanzapine-samidorphan + exercise

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: olanzapine-samidorphan plus exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight

Body weight

Time frame
4 weeks

Secondary outcomes

1

Weight

4 weeks post formal exercise program

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

Source ClinicalTrials.gov
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