Neuronal Effects of Exercise in Schizophrenia

NCT ID: NCT02455193

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exercise intervention

10 weeks of a moderate exercise intervention

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Diet intervention

10 weeks of a diet intervention

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type BEHAVIORAL

Interventions

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Exercise

Intervention Type BEHAVIORAL

Diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Tregellas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristina T Legget, Ph.D.

Role: CONTACT

303-724-5809

Facility Contacts

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Kristina T Legget, PhD

Role: primary

303-724-5809

Other Identifiers

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UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH102224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1282

Identifier Type: -

Identifier Source: org_study_id

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