Neuronal Effects of Exercise in Schizophrenia

April 21, 2025 updated by: University of Colorado, Denver
This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Between 21 and 70 years of age
  • Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications
  • Weight stable within 5 percent for the last 6 months

Exclusion Criteria:

  • Pregnancy
  • Substance abuse
  • Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
  • MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise intervention
10 weeks of a moderate exercise intervention
Behavioral: Exercise
Active Comparator: Diet intervention
10 weeks of a diet intervention
Behavioral: Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuronal response to visual food cues
Time Frame: 14 weeks
Neuronal response (insula) while viewing visual food cues
14 weeks
Resting-state neuronal response
Time Frame: 14 weeks
Neuronal response (default mode network) during rest
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite Rating on a visual analogue scale (VAS)
Time Frame: 14 weeks
Participants will be asked to rate their hunger via Hunger ratings on a VAS
14 weeks
Fasting leptin
Time Frame: 14 weeks
Fasting blood levels of leptin
14 weeks
Fasting ghrelin
Time Frame: 14 weeks
Fasting blood levels of ghrelin
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)
National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Jason Tregellas, Ph.D., University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimated)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1282
  • UL1TR001082 (U.S. NIH Grant/Contract)
  • R01MH102224 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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