SchizophreniaNCT02455193
Neuronal Effects of Exercise in Schizophrenia
A study testing Exercise and Diet in people with Schizophrenia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Substance abuse
- Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
- MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Kristina T Legget, PhD, 303-724-5809, kristina.legget@ucdenver.edu
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- Exercise, Diet
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
DietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 10 weeks of a moderate exercise intervention Receives: Behavioral: Exercise |
| Diet intervention | Active comparator | 10 weeks of a diet intervention Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal response to visual food cues
Neuronal response (insula) while viewing visual food cues
Measured: 14 weeks
Resting-state neuronal response
Neuronal response (default mode network) during rest
Measured: 14 weeks
Secondary outcomes (3)
Appetite Rating on a visual analogue scale (VAS)
Participants will be asked to rate their hunger via Hunger ratings on a VAS
Measured: 14 weeks
Fasting leptin
Fasting blood levels of leptin
Measured: 14 weeks
Fasting ghrelin
Fasting blood levels of ghrelin
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jason Tregellas, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455193
- Sponsor's protocol ID
- 14-1282
- Other IDs
- UL1TR001082, R01MH102224
- Status last verified
- Apr 2025
- First submitted
- 21 May 2015
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Effects of Exercise in Schizophrenia
- ClinicalTrials.gov ID
- NCT02455193
- Acronym / sponsor ID
- 14-1282
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- Aug 2014
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise10 weeks of a moderate exercise intervention |
| Diet intervention | Active comparator | Behavioral: Diet10 weeks of a diet intervention |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Substance abuse
- Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
- MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Behavioural | Exercise intervention |
| Diet | Behavioural | Diet intervention |
Primary outcome
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
3 secondary outcomes
Appetite Rating on a visual analogue scale (VAS)
Time frame: 14 weeks
Fasting leptin
Time frame: 14 weeks
Fasting ghrelin
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Tregellas, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Diet in people with Schizophrenia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina T Legget, Ph.D. (303-724-5809, kristina.legget@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuronal response to visual food cues (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.