Neuronal Effects of Exercise in Schizophrenia
3 other identifiers
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Aug 2014
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 22, 2025
April 1, 2025
11.1 years
May 21, 2015
April 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Neuronal response to visual food cues
Neuronal response (insula) while viewing visual food cues
14 weeks
Resting-state neuronal response
Neuronal response (default mode network) during rest
14 weeks
Secondary Outcomes (3)
Appetite Rating on a visual analogue scale (VAS)
14 weeks
Fasting leptin
14 weeks
Fasting ghrelin
14 weeks
Study Arms (2)
Exercise intervention
EXPERIMENTAL10 weeks of a moderate exercise intervention
Diet intervention
ACTIVE COMPARATOR10 weeks of a diet intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Substance abuse
- Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Tregellas, Ph.D.
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
May 27, 2015
Study Start
August 1, 2014
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
April 22, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share