NCT02455193 · University of Colorado, Denver
Neuronal Effects of Exercise in Schizophrenia
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Exercise
BEHAVIORAL
Diet
Primary outcome measures
Neuronal response to visual food cues
Time frame: 14 weeks
Neuronal response (insula) while viewing visual food cues
Resting-state neuronal response
Time frame: 14 weeks
Neuronal response (default mode network) during rest
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Substance abuse
- Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
- MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Where
- Aurora, Colorado
Collaborators
National Institute of Mental Health (NIMH), National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2025 · Source of record for eligibility and locations