Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00838227
Status:
WITHDRAWN
Last Update Posted:
2020-10-14
First Post:
2009-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No source of funding to implement the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2009-02-05', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)', 'timeFrame': '8 weeks', 'description': 'Study withdrawn due to lack of funds.'}], 'secondaryOutcomes': [{'measure': 'Sedation and weight changes', 'timeFrame': '8 weeks', 'description': 'Study withdrawn due to lack of funds.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Cognition', 'Obesity', 'Sedation'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '19026265', 'type': 'BACKGROUND', 'citation': 'Saavedra-Velez C, Yusim A, Anbarasan D, Lindenmayer JP. Modafinil as an adjunctive treatment of sedation, negative symptoms, and cognition in schizophrenia: a critical review. J Clin Psychiatry. 2009 Jan;70(1):104-12. doi: 10.4088/jcp.07r03982. Epub 2008 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens', 'detailedDescription': 'This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years\n* Auditory and visual acuity adequate to complete cognitive tests\n* Stable dose of antipsychotics for at least 2 weeks prior to entry\n* Good physical health determined by complete physical examination, laboratory tests, and EKG\n* Capacity and willingness to give written informed consent.\n\nExclusion Criteria:\n\n* Inability to read or speak English\n* Documented disease of the central nervous system\n* History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)\n* Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;\n* HIV positive\n* Patients on antidepressants, including monoamine oxidase inhibitors\n* Uncontrolled hypertension\n* Pregnancy\n* Patients with a current diagnosis of substance dependence\n* Significant history of violence\n* History of an eating disorder\n* Ready for discharge within the following 8 weeks.'}, 'identificationModule': {'nctId': 'NCT00838227', 'briefTitle': 'Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Psychiatric Center'}, 'officialTitle': 'Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study', 'orgStudyIdInfo': {'id': '07I/C41-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One arm', 'description': 'Study withdrawn due to lack of funds.', 'interventionNames': ['Drug: modafinil']}], 'interventions': [{'name': 'modafinil', 'type': 'DRUG', 'otherNames': ['Provigil'], 'description': 'Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen', 'armGroupLabels': ['One arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Pierre Lindenmayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Psychiatric Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Psychiatric Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Jean-Pierre Lindenmayer', 'investigatorAffiliation': 'Manhattan Psychiatric Center'}}}}