Neuronal Effects of Exercise in Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenia

• Registration Number: NCT02455193
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting-state neuronal response	14 weeks	Neuronal response (default mode network) during rest
Neuronal response to visual food cues	14 weeks	Neuronal response (insula) while viewing visual food cues

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States