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Neuronal Effects of Exercise in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02455193
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : December 20, 2021
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Exercise Behavioral: Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neuronal Effects of Exercise in Schizophrenia
Study Start Date : August 2014
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Neuronal response to visual food cues [ Time Frame: 14 weeks ]
    Neuronal response (insula) while viewing visual food cues

  2. Resting-state neuronal response [ Time Frame: 14 weeks ]
    Neuronal response (default mode network) during rest

Secondary Outcome Measures :
  1. 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

  2. Fasting leptin [ Time Frame: 14 weeks ]
    Fasting blood levels of leptin

  3. Fasting ghrelin [ Time Frame: 14 weeks ]
    Fasting blood levels of ghrelin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02455193

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Contact: Kristina T Legget, Ph.D. 303-724-5809

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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristina T Legget, PhD    303-724-5809   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Mental Health (NIMH)
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Principal Investigator: Jason Tregellas, Ph.D. University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT02455193    
Other Study ID Numbers: 14-1282
UL1TR001082 ( U.S. NIH Grant/Contract )
R01MH102224 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders