Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-29 @ 2:43 PM
Study NCT ID:
NCT00812058
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2008-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014529', 'term': 'Uridine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-13', 'studyFirstSubmitDate': '2008-12-18', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MADRS Score', 'timeFrame': 'Baseline and weekly for 8 weeks'}], 'secondaryOutcomes': [{'measure': 'CGI-BP-S', 'timeFrame': 'Baseline and weekly for 8 weeks'}, {'measure': 'Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)', 'timeFrame': 'Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bipolar Depression', 'Bipolar Disease', 'Bipolar Disorder', 'Bipolar', 'Manic Depression', 'Manic Depressive Disorder'], 'conditions': ['Bipolar I Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar I Disorder, most recent episode depressed\n* History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms\n\nExclusion Criteria:\n\n* Current manic, hypomanic or mixed episode\n* Rapid cycling bipolar disorder (4 or more mood episodes in the last year)\n* Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment\n* Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months\n* Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)\n* Axis II diagnosis likely to interfere with study compliance\n* Serious suicidal or homicidal risk\n* Sensitivity to any of the drug ingredients, including lactose\n* Women who are pregnant, breast feeding or refuse to use adequate birth control\n* Current seizure disorder\n* Current episode of depression is longer than 1 year'}, 'identificationModule': {'nctId': 'NCT00812058', 'briefTitle': 'A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repligen Corporation'}, 'officialTitle': 'A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression', 'orgStudyIdInfo': {'id': 'RG2417-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RG2417', 'description': 'Oral RG2417 taken twice daily for 8 weeks', 'interventionNames': ['Drug: RG2417']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo taken twice daily for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RG2417', 'type': 'DRUG', 'otherNames': ['Uridine'], 'description': '1g bid dose escalates to 2g bid for weeks 2-8.', 'armGroupLabels': ['RG2417']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Psychiatry Pharmaceutical Studies, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72201', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'K&S Professional Research Services', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Affiliated Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Behavioral Clinical Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solution, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida College of Medicine', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Carman Research', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Valle Vista Health System', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Department of Pscyhiatry & Psychology', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Behavioral Medical Research of States Island', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unvieristy of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Richard H. Weisler, MD, PA and Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Midwest Clinical Research Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'IPS Research Company', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Clinical Investigations, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02856', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lincoln Research', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CNS Healthcare', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Houston Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '53562', 'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Foundation', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}], 'overallOfficials': [{'name': 'Gary Sachs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repligen Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hedy Dion', 'oldOrganization': 'Repligen Corporation'}}}}