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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I have been diagnosed with schizophrenia or schizoaffective disorder.
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I am taking olanzapine, risperidone, clozapine, or haloperidol, or I am not on any neuroleptic medications.
Select...
I am between 21 and 70 years old.

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

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

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
~760

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,609 Total Patients Enrolled
2 Trials studying Schizophrenia
96 Patients Enrolled for Schizophrenia
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,386 Total Patients Enrolled
9 Trials studying Schizophrenia
201 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,627 Total Patients Enrolled
249 Trials studying Schizophrenia
89,295 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial open its doors to elderly individuals?

"For this trial to be a success, individuals between the ages of 21 and 70 need to be recruited."

Answered by AI

How many participants are helping to evaluate this medical research?

"Affirmative. The data posted on clinicaltrials.gov suggests that this research project is currently recruiting patients; the trial was first published on August 1st 2014 and was most recently updated on August 10th 2022. Thus far, they have managed to recruit 140 people from a single location."

Answered by AI

May I partake in this clinical trial?

"The ongoing trial is seeking 140 individuals with schizophrenia, ranging in age from 21 to 70. To be considered for the study they must either have been prescribed olanzapine, risperidone, clozapine or haloperidol by a doctor or not currently taking any neuroleptic medications; and must have had stable body weight within 5% over the last 6 months."

Answered by AI

Is this trial actively seeking volunteers at the moment?

"According to clinicaltrials.gov, this trial is actively attempting to enroll volunteers for the study which began on August 1st 2014 and was modified recently on August 10th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Neuronal Effects of Exercise in Schizophrenia
2014. "Neuronal Effects of Exercise in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02455193.
All > Schizophrenia > Paid Studies Colorado
~15 spots leftby Jul 2025
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