Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 6:34 PM
Study NCT ID:
NCT01246908
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'C551866', 'term': 'CX157'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-08', 'studyFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Over six weeks of study treatment', 'description': 'The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.'}], 'secondaryOutcomes': [{'measure': 'Severity of illness (CGI-S);', 'timeFrame': 'Over six weeks of treatment with study drug.', 'description': 'To measure severity of depression'}, {'measure': 'Global Improvement (CGI-I)', 'timeFrame': 'Over six weeks of treatment', 'description': 'To measure overall improvment.'}, {'measure': 'Hospital Anxiety Depression Rating Scale (HADS)', 'timeFrame': 'over six weeks of treatment', 'description': 'To measure symptoms of depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TRD'], 'conditions': ['Treatment Resistant Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if CX157 is effective and safe in patients with treatment of treatment resistant depression over six weeks of treatment.', 'detailedDescription': 'The primary objective of this study is to examine the efficacy of CX157 Modified Release Tablet, 125 mg administered twice per day (BID) as compared to placebo in subjects with Treatment Resistant Depression (TRD). Secondary objectives are to evaluate the safety and tolerability of CX157 Modified Release Tablet, 125 mg BID in TRD subjects and characterize steady-state pharmacokinetic profile and explore pharmacodynamic relationships.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, 20 to 65 years of age\n2. Able to read, understand and converse in English and provide written, dated informed consent\n3. Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD)\n4. Females on acceptable method of contraception\n\nExclusion Criteria:\n\n1. Major depressive episode greater than five years\n2. A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months\n3. Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD\n4. A history of schizophrenia or schizoaffective disorders\n5. A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years\n6. A history of Antisocial Personality Disorder or Borderline Personality Disorder\n7. Recent suicidal behavior and is at risk of such behavior during the course of the study\n8. Electroconvulsive therapy (ECT) within the past five years\n9. Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression\n10. Vagus Nerve Stimulation (VNS) at any time\n11. Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug\n12. Significant abnormality on the screening physical examination\n13. Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris\n14. A history within the past two years of significant head trauma, surgical procedure involving the brain,degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation\n15. A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months\n16. A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening\n17. Participation in an investigational study in the past one month\n18. A positive screening urine test for drugs of abuse\n19. Female subject who is pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT01246908', 'acronym': 'CX157-201', 'briefTitle': 'Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'CeNeRx BioPharma Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 Modified Release Tablet, 125 mg Twice Per Day in Subjects With Treatment Resistant Depression', 'orgStudyIdInfo': {'id': 'CX157-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CX157 (TriRima)', 'description': 'CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)', 'interventionNames': ['Drug: CX157 (TriRima)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Placebo administered twice per day for six weeks.', 'armGroupLabels': ['Placebo']}, {'name': 'CX157 (TriRima)', 'type': 'DRUG', 'description': 'One tablet administered twice per day (total daily dose of 250 mg) for six weeks.', 'armGroupLabels': ['CX157 (TriRima)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Escondido', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'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': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Clinical Research Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Segal Institute of Clinical Research', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33163', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida College of Medicine Psychiatry Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Stedman Clinical Trials', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Kolin Research Group', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Institute of Medicine and Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Nathan Shapira, MD, Ph.D', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AccelRx Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Eastside Comprehensive Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Richard H. Weisler, M.D. and Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'NorthCoast Clinical Trials, Inc.', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '45215', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Patient Priority Clinical Sites, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Star Medical Research, LLC', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Clinical Investigations, Inc', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Summitt Research Network (Oregon)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18915', 'city': 'Colmar', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Introspect of Buxmont, Ltd', 'geoPoint': {'lat': 40.26733, 'lon': -75.25351}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Neurosciences Solutions, Inc.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78754', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Community Clinical Research, Inc.', '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': '84123', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98007', '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 (Seattle) LLC', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53223', 'city': 'Deer Brown', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Northbrooke Research Center'}], 'overallOfficials': [{'name': 'Alan Yeo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summitt Research Network - Oregon'}, {'name': 'Ram Shrivastava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastside Comprehensive Medical Center'}, {'name': 'Angelo Sambunaris, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Institute of Medicine and Research'}, {'name': 'Bijan Bastani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NorthCoast Clinical Trials'}, {'name': 'Mary Stedman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stedman Clinical Trials'}, {'name': 'Richard Weisler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Richard H. Weisler, M.D. and Associates'}, {'name': 'Mark Joyce, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Neuroscience Solutions, Inc.'}, {'name': 'Fares Arguello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research'}, {'name': 'Valerie Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Neurosciences Solutions, Inc.'}, {'name': 'Arif Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Clinical Research Center'}, {'name': 'Irving Kolin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kolin Research Group'}, {'name': 'Jelena Kunovac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Excell Research'}, {'name': 'Jerry Steiert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summit Research Network (Seattle) LLC'}, {'name': 'Lorena Wallhauser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Patient Priority Clinical Sites, LLC'}, {'name': 'Mohammed Bari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Synergy Clinical Research Center'}, {'name': 'Prakash Bhatia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Synergy Escondido'}, {'name': 'Michael Downing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FutureSearch Trials of Dallas'}, {'name': 'David Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Clinical Research, Inc.'}, {'name': 'Rosario Hidalgo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida College of Medicine Psychiatry Center'}, {'name': 'Alec Bodkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}, {'name': 'Russell Pet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AccelRx Research'}, {'name': 'Beal Essink, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Center for Clinical Investigations, Inc'}, {'name': 'Scott Segal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Segal Institute of Clinical Research'}, {'name': 'Jeffrey Simon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northbrooke Research Center'}, {'name': 'Charmaine Semeniuk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pacific Clinical Research'}, {'name': 'John Prater, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulfcoast Clinical Research Center'}, {'name': 'Mark Woyshville, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Star Medical Research LLC'}, {'name': 'Nathan Shapira, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carman Research'}, {'name': 'Robert Molpus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Neuroscience Solutions, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CeNeRx BioPharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}