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NCT Number: NCT02455193

Neuronal Effects of Exercise in Schizophrenia

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.

Recruiting

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Kristina T Legget, PhD

CONTACT

[email protected]

303-724-5809

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

Diet

Behavioral

Primary outcomes

  1. Neuronal response to visual food cues

    Time frame: 14 weeks

    Neuronal response (insula) while viewing visual food cues

  2. Resting-state neuronal response

    Time frame: 14 weeks

    Neuronal response (default mode network) during rest

Secondary outcomes

  1. Appetite Rating on a visual analogue scale (VAS)

    Time frame: 14 weeks

    Participants will be asked to rate their hunger via Hunger ratings on a VAS

  2. Fasting leptin

    Time frame: 14 weeks

    Fasting blood levels of leptin

  3. Fasting ghrelin

    Time frame: 14 weeks

    Fasting blood levels of ghrelin

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina T Legget, Ph.D.

CONTACT

[email protected]

303-724-5809

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
May 27, 2015
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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