Back to resultsNeuronal Effects of Exercise in Schizophrenia
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Diet
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
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)
Sites / Locations
- University of Colorado Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise intervention
Diet intervention
Arm Description
10 weeks of a moderate exercise intervention
10 weeks of a diet intervention
Outcomes
Primary Outcome Measures
Neuronal response to visual food cues
Neuronal response (insula) while viewing visual food cues
Resting-state neuronal response
Neuronal response (default mode network) during rest
Secondary Outcome Measures
Appetite Rating on a visual analogue scale (VAS)
Participants will be asked to rate their hunger via Hunger ratings on a VAS
Fasting leptin
Fasting blood levels of leptin
Fasting ghrelin
Fasting blood levels of ghrelin
Full Information
NCT ID
NCT02455193
First Posted
May 21, 2015
Last Updated
August 10, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02455193
Brief Title
Neuronal Effects of Exercise in Schizophrenia
Official Title
Neuronal Effects of Exercise in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
10 weeks of a moderate exercise intervention
Arm Title
Diet intervention
Arm Type
Active Comparator
Arm Description
10 weeks of a diet intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Type
Behavioral
Intervention Name(s)
Diet
Primary Outcome Measure Information:
Title
Neuronal response to visual food cues
Description
Neuronal response (insula) while viewing visual food cues
Time Frame
14 weeks
Title
Resting-state neuronal response
Description
Neuronal response (default mode network) during rest
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Appetite Rating on a visual analogue scale (VAS)
Description
Participants will be asked to rate their hunger via Hunger ratings on a VAS
Time Frame
14 weeks
Title
Fasting leptin
Description
Fasting blood levels of leptin
Time Frame
14 weeks
Title
Fasting ghrelin
Description
Fasting blood levels of ghrelin
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina T Legget, Ph.D.
Phone
303-724-5809
Email
kristina.legget@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Tregellas, Ph.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina T Legget, PhD
Phone
303-724-5809
Email
kristina.legget@ucdenver.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuronal Effects of Exercise in Schizophrenia
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