Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-07 @ 12:06 AM
Study NCT ID:
NCT02455193
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuronal Effects of Exercise in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-05-22', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuronal response to visual food cues', 'timeFrame': '14 weeks', 'description': 'Neuronal response (insula) while viewing visual food cues'}, {'measure': 'Resting-state neuronal response', 'timeFrame': '14 weeks', 'description': 'Neuronal response (default mode network) during rest'}], 'secondaryOutcomes': [{'measure': 'Appetite Rating on a visual analogue scale (VAS)', 'timeFrame': '14 weeks', 'description': 'Participants will be asked to rate their hunger via Hunger ratings on a VAS'}, {'measure': 'Fasting leptin', 'timeFrame': '14 weeks', 'description': 'Fasting blood levels of leptin'}, {'measure': 'Fasting ghrelin', 'timeFrame': '14 weeks', 'description': 'Fasting blood levels of ghrelin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder\n* Between 21 and 70 years of age\n* Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications\n* Weight stable within 5 percent for the last 6 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Substance abuse\n* Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)\n* MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)'}, 'identificationModule': {'nctId': 'NCT02455193', 'briefTitle': 'Neuronal Effects of Exercise in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Neuronal Effects of Exercise in Schizophrenia', 'orgStudyIdInfo': {'id': '14-1282'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}, {'id': 'R01MH102224', 'link': 'https://reporter.nih.gov/quickSearch/R01MH102224', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise intervention', 'description': '10 weeks of a moderate exercise intervention', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diet intervention', 'description': '10 weeks of a diet intervention', 'interventionNames': ['Behavioral: Diet']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Exercise intervention']}, {'name': 'Diet', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Diet intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristina T Legget, PhD', 'role': 'CONTACT', 'email': 'kristina.legget@ucdenver.edu', 'phone': '303-724-5809'}], 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Kristina T Legget, Ph.D.', 'role': 'CONTACT', 'email': 'kristina.legget@ucdenver.edu', 'phone': '303-724-5809'}], 'overallOfficials': [{'name': 'Jason Tregellas, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}