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Diet and Exercise for Schizophrenia

N/A
Recruiting
Led By Jason Tregellas, Ph.D.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of schizophrenia or schizoaffective disorder
Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications
Must not have
Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how drugs for schizophrenia can lead to weight gain, and how diet and exercise may help. They will look at how people's brains react to food, and ask about eating habits and symptoms. Some participants may do an exercise or diet intervention.

Who is the study for?
This trial is for adults aged 21-70 with schizophrenia or schizoaffective disorder, who are either on olanzapine, risperidone, clozapine, haloperidol or not on neuroleptic medications. They should have had a stable weight in the past 6 months. Pregnant individuals, those with substance abuse issues or significant metabolic diseases, and anyone unable to undergo MRI due to claustrophobia or metal implants cannot participate.
What is being tested?
The study examines how diet and exercise affect brain response to food images and preferences in people taking common schizophrenia drugs that may cause weight gain. Participants will be asked about their eating habits and symptoms and might do an exercise or diet program to see if it changes how their brain reacts to food.
What are the potential side effects?
While the trial itself does not directly involve medication side effects, participants may experience general discomfort from engaging in new dietary practices or exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Select...
I am taking olanzapine, risperidone, clozapine, or haloperidol, or I am not on any neuroleptic medications.
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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe uncontrolled blood pressure or very high blood fat levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neuronal response to visual food cues
Resting-state neuronal response
Secondary study objectives
Appetite Rating on a visual analogue scale (VAS)
Fasting ghrelin
Fasting leptin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise interventionExperimental Treatment1 Intervention
10 weeks of a moderate exercise intervention
Group II: Diet interventionActive Control1 Intervention
10 weeks of a diet intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~820

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
369 Previous Clinical Trials
412,724 Total Patients Enrolled
3 Trials studying Schizophrenia
167 Patients Enrolled for Schizophrenia
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,737 Total Patients Enrolled
9 Trials studying Schizophrenia
201 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,993 Total Patients Enrolled
254 Trials studying Schizophrenia
89,891 Patients Enrolled for Schizophrenia
~7 spots leftby Jul 2025
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