Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-03-05 @ 11:38 AM
Study NCT ID:
NCT00448292
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2007-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511631', 'term': 'naluzotan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-09', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).', 'timeFrame': 'change from baseline through end of study'}], 'secondaryOutcomes': [{'measure': 'Side effects during and immediately following the treatment period', 'timeFrame': 'assessed throughout study'}, {'measure': 'changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale', 'timeFrame': 'change from baseline through end of study'}, {'measure': 'changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)', 'timeFrame': 'change from baseline through end of study'}, {'measure': 'changes from baseline on the Clinical Global Impressions (CGI) scale', 'timeFrame': 'change from baseline through end of study'}, {'measure': 'responder and remission rates', 'timeFrame': 'change from baseline through end of study'}, {'measure': 'changes from baseline on the Changes in Sexual Function (CSFQ) scale.', 'timeFrame': 'change from baseline through end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Major Depressive Disorder', 'Major Depression', 'MDD'], 'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.', 'detailedDescription': 'Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of major depressive disorder\n\nKey Exclusion Criteria:\n\n* Females who are pregnant or nursing\n* Electroconvulsive therapy within previous year\n* Type 1 diabetes or uncontrolled type 2 diabetes\n* HIV, Hepatitis B or Hepatitis C\n* Use of illegal drugs, history of drug abuse, and/or alcohol dependence\n* Clinically significant abnormal lab results\n\nOther protocol-defined eligibility criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00448292', 'briefTitle': 'A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epix Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.', 'orgStudyIdInfo': {'id': 'EPX-CP-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg', 'interventionNames': ['Drug: PRX-00023']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg', 'interventionNames': ['Drug: Placebo for PRX-00023']}], 'interventions': [{'name': 'PRX-00023', 'type': 'DRUG', 'description': 'Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.', 'armGroupLabels': ['1']}, {'name': 'Placebo for PRX-00023', 'type': 'DRUG', 'description': 'Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Vista Medical Research, Inc.', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Clinical Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research Medical Group', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'AVI Clinical Research', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research Medical Group', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GWU Clinical Psychiatric Research Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'CNS Healthcare of Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute of Medicine and Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Research Center, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Brentwood Research Institute', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '28216', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Neuropsychiatry', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvannia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'SE Health Consultants, LLC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'facility': 'R/D Clinical Research, Inc.', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Summit Research Network', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epix Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}