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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02455193
Other study ID # 14-1282
Secondary ID UL1TR001082R01MH
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date July 2025

Study information

Verified date February 2024
Source University of Colorado, Denver
Contact Kristina T Legget, Ph.D.
Phone 303-724-5809
Email kristina.legget@ucdenver.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise

Diet


Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver National Center for Advancing Translational Sciences (NCATS), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuronal response to visual food cues Neuronal response (insula) while viewing visual food cues 14 weeks
Primary Resting-state neuronal response Neuronal response (default mode network) during rest 14 weeks
Secondary Appetite Rating on a visual analogue scale (VAS) Participants will be asked to rate their hunger via Hunger ratings on a VAS 14 weeks
Secondary Fasting leptin Fasting blood levels of leptin 14 weeks
Secondary Fasting ghrelin Fasting blood levels of ghrelin 14 weeks
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