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Neuronal Effects of Exercise in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02455193
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):

Study Description
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 patients' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask patients to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

Condition or disease Intervention/treatment
Schizophrenia Behavioral: Exercise Behavioral: Diet

Study Design

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 : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
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% 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)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02455193

Contact: Kristina T Legget, Ph.D. 303-724-5809 kristina.legget@ucdenver.edu

United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristina T Legget, PhD    303-724-5809    kristina.legget@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Principal Investigator: Jason Tregellas, Ph.D. University of Colorado, Denver
More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02455193     History of Changes
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: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders