Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-03 @ 11:14 AM
Study NCT ID:
NCT01776112
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Synaptic Plasticity and Cognition in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2012-01-01', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hippocampal volume', 'timeFrame': 'after three months of exercise', 'description': 'Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders'}], 'secondaryOutcomes': [{'measure': 'Verbal Learning Memory', 'timeFrame': 'after three months of exercise', 'description': 'Neuropsychological assessment of a working memory domain via the Verbal Learning Memory Test (German: Helmstaedter, C., Lendt, M., Lux, S., 2001. Verbaler Lern- und Merkfähigkeitstest (VLMT). Göttingen, Beltz)'}, {'measure': 'Positive and negative symptoms', 'timeFrame': 'after three months of exercise', 'description': 'Measurement of positive and negative symptoms of schizophrenia using the "Positive and Negative Symptom Scale for Schizophrenia" (Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'negative symptoms', 'cognitive deficits', 'synaptic plasticity'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '20124113', 'type': 'BACKGROUND', 'citation': 'Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.'}]}, 'descriptionModule': {'briefSummary': 'To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria)\n* Age between 18 and 55\n* Verbal IQ ≥ 85\n* Stable psychopathology on constant medication for 2 weeks\n* Informed consent.\n\nExclusion Criteria:\n\nPatients, who are\n\n* not willing or able to participate in the sports program and cognitive training\n* reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score)\n* have an organic mental disorder (such as intoxication or neurological disorders of the CNS)\n* suffer from instable somatic diseases\n* have an active substance abuse'}, 'identificationModule': {'nctId': 'NCT01776112', 'acronym': 'EXERCISE-II', 'briefTitle': 'Enhancing Synaptic Plasticity and Cognition in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Goettingen'}, 'officialTitle': 'Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'UMCG-EX-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SZ-Exercise', 'description': 'Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.', 'interventionNames': ['Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SZ-TableSoccer', 'description': 'Standard treatment and participation in an activity without physical improvement as placebo condition (table soccer in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.', 'interventionNames': ['Other: TableSoccer']}, {'type': 'EXPERIMENTAL', 'label': 'HC-Exercise', 'description': 'Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.', 'armGroupLabels': ['HC-Exercise', 'SZ-Exercise']}, {'name': 'TableSoccer', 'type': 'OTHER', 'description': 'Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.', 'armGroupLabels': ['SZ-TableSoccer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'overallOfficials': [{'name': 'Peter Falkai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610'}, {'name': 'Andrea Schmitt, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610'}, {'name': 'Berend Malchow, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Senior Consultant, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Goettingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Peter Falkai', 'investigatorFullName': 'Prof. Dr. Peter Falkai', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}