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 : December 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Behavioral: Exercise Behavioral: Diet | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Exercise intervention
10 weeks of a moderate exercise intervention
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Behavioral: Exercise |
Active Comparator: Diet intervention
10 weeks of a diet intervention
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Behavioral: Diet |
- Neuronal response to visual food cues [ Time Frame: 14 weeks ]Neuronal response (insula) while viewing visual food cues
- Resting-state neuronal response [ Time Frame: 14 weeks ]Neuronal response (default mode network) during rest
- 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
- Fasting leptin [ Time Frame: 14 weeks ]Fasting blood levels of leptin
- Fasting ghrelin [ Time Frame: 14 weeks ]Fasting blood levels of ghrelin

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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)

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 |
Principal Investigator: | Jason Tregellas, Ph.D. | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov 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 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |