Neuronal Effects of Exercise in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Diet.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 21 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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]
- Resting-state neuronal response [Time frame: 14 weeks]
Secondary outcome measures (3)
- Appetite Rating on a visual analogue scale (VAS) [Time frame: 14 weeks]
- Fasting leptin [Time frame: 14 weeks]
- Fasting ghrelin [Time frame: 14 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT02455193 · 14-1282 · UL1TR001082 · R01MH102224