Recruiting

Schizophrenia & Weight Gain

Sponsor:

University of Colorado, Denver

Code:

NCT02455193

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Exercise

Diet

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT02455193

Start date

Aug, 2014

Status verified date

Apr, 2025

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Exercise intervention

10 weeks of a moderate exercise intervention

active comparator: Diet intervention

10 weeks of a diet intervention

Interventions

Exercise

Diet

Primary outcome measure

  • Neuronal response to visual food cues [ Time Frame: 14 weeks ]
  • Resting-state neuronal response [ Time Frame: 14 weeks ]

Central Contacts and Locations

Central contacts

Kristina T Legget, Ph.D.

303-724-5809kristina.legget@ucdenver.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kristina T Legget, PhD

303-724-5809kristina.legget@ucdenver.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 22, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-22.