Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT00060905
Status:
COMPLETED
Last Update Posted:
2006-08-04
First Post:
2003-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'statusVerifiedDate': '2006-08', 'lastUpdateSubmitDate': '2006-08-02', 'studyFirstSubmitDate': '2003-05-15', 'studyFirstSubmitQcDate': '2003-05-15', 'lastUpdatePostDateStruct': {'date': '2006-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),'}, {'measure': 'BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.'}]}, 'conditionsModule': {'keywords': ['Bipolar Disorder (manic or mixed type)'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '20361904', 'type': 'DERIVED', 'citation': 'Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.'}, {'pmid': '17107240', 'type': 'DERIVED', 'citation': 'Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Current primary diagnosis of bipolar I disorder, mania or mixed type\n* Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score \\>= 18\n* Hospitalized no more than 7 days at time of Screening or in process of being admitted\n* History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement\n\nEXCLUSION CRITERIA\n\n* History of schizophrenia or schizoaffective disorder\n* Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results\n* Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)\n* Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)\n* Had first manic episode after age 60\n* Has ever taken clozapine\n* Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug\n* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines\n* History of active alcohol or substance dependence within past 3 months.\n* History of failed treatment on adequate valproate therapy for bipolar disorder\n* Has taken Depakote (DR or ER) regularly over the last 30 days\n* Has serious violent, homicidal, or suicidal ideation'}, 'identificationModule': {'nctId': 'NCT00060905', 'briefTitle': 'An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder', 'orgStudyIdInfo': {'id': 'M02-540'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Divalproex Sodium (Depakote ER)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Neuroscience of SCA', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'AVI Clinical Research', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60194', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mark Lerman, MD', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Bipolar Research Program', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Brentwood Research Inst.', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centers for Behavioral Health, LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}, {'zip': '48047', 'city': 'Baltimore', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pioneer Research'}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '08021', 'city': 'Clementon', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Steven A. Glass, MD', 'geoPoint': {'lat': 39.8115, 'lon': -74.98294}}, {'zip': '11423', 'city': 'Holliswood', 'state': 'New York', 'country': 'United States', 'facility': 'The Holliswood Hospital', 'geoPoint': {'lat': 40.71119, 'lon': -73.76249}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine - Bellevue', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Mental Sciences Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78223', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio State Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22041', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'CNS of Northern Virginia', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'VAMC', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Global Medical Information - Abbott', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}