Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
NCT ID: NCT01246908
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
360 participants
INTERVENTIONAL
2010-11-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CX157 (TriRima)
CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)
CX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
Placebo
Placebo
Placebo administered twice per day for six weeks.
Interventions
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Placebo
Placebo administered twice per day for six weeks.
CX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to read, understand and converse in English and provide written, dated informed consent
3. Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD)
4. Females on acceptable method of contraception
Exclusion Criteria
2. A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months
3. Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD
4. A history of schizophrenia or schizoaffective disorders
5. A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years
6. A history of Antisocial Personality Disorder or Borderline Personality Disorder
7. Recent suicidal behavior and is at risk of such behavior during the course of the study
8. Electroconvulsive therapy (ECT) within the past five years
9. Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression
10. Vagus Nerve Stimulation (VNS) at any time
11. Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug
12. Significant abnormality on the screening physical examination
13. Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris
14. 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
15. A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months
16. A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening
17. Participation in an investigational study in the past one month
18. A positive screening urine test for drugs of abuse
19. Female subject who is pregnant or lactating
20 Years
65 Years
ALL
No
Sponsors
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CeNeRx BioPharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Yeo, MD
Role: PRINCIPAL_INVESTIGATOR
Summitt Research Network - Oregon
Ram Shrivastava, MD
Role: PRINCIPAL_INVESTIGATOR
Eastside Comprehensive Medical Center
Angelo Sambunaris, M.D.
Role: PRINCIPAL_INVESTIGATOR
Atlanta Institute of Medicine and Research
Bijan Bastani, M.D.
Role: PRINCIPAL_INVESTIGATOR
NorthCoast Clinical Trials
Mary Stedman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Stedman Clinical Trials
Richard Weisler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Richard H. Weisler, M.D. and Associates
Mark Joyce, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinical Neuroscience Solutions, Inc.
Fares Arguello, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research
Valerie Arnold, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Neurosciences Solutions, Inc.
Arif Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Clinical Research Center
Irving Kolin, MD
Role: PRINCIPAL_INVESTIGATOR
Kolin Research Group
Jelena Kunovac, MD
Role: PRINCIPAL_INVESTIGATOR
Excell Research
Jerry Steiert, MD
Role: PRINCIPAL_INVESTIGATOR
Summit Research Network (Seattle) LLC
Lorena Wallhauser, MD
Role: PRINCIPAL_INVESTIGATOR
Patient Priority Clinical Sites, LLC
Mohammed Bari, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Clinical Research Center
Prakash Bhatia, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Escondido
Michael Downing, MD
Role: PRINCIPAL_INVESTIGATOR
FutureSearch Trials of Dallas
David Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Community Clinical Research, Inc.
Rosario Hidalgo, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida College of Medicine Psychiatry Center
Alec Bodkin, MD
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Russell Pet, MD
Role: PRINCIPAL_INVESTIGATOR
AccelRx Research
Beal Essink, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oregon Center for Clinical Investigations, Inc
Scott Segal, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Segal Institute of Clinical Research
Jeffrey Simon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northbrooke Research Center
Charmaine Semeniuk, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pacific Clinical Research
John Prater, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gulfcoast Clinical Research Center
Mark Woyshville, M.D.
Role: PRINCIPAL_INVESTIGATOR
North Star Medical Research LLC
Nathan Shapira, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Carman Research
Robert Molpus, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Neuroscience Solutions, Inc.
Locations
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Synergy Escondido
Escondido, California, United States
Synergy Clinical Research Center
National City, California, United States
Excell Research
Oceanside, California, United States
Pacific Clinical Research
Orange, California, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
The Segal Institute of Clinical Research
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
University of South Florida College of Medicine Psychiatry Center
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
Nathan Shapira, MD, Ph.D
Smyrna, Georgia, United States
McLean Hospital
Belmont, Massachusetts, United States
AccelRx Research
Fall River, Massachusetts, United States
Eastside Comprehensive Medical Center
New York, New York, United States
Richard H. Weisler, M.D. and Associates
Raleigh, North Carolina, United States
NorthCoast Clinical Trials, Inc.
Beachwood, Ohio, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
Oregon Center for Clinical Investigations, Inc
Portland, Oregon, United States
Summitt Research Network (Oregon)
Portland, Oregon, United States
Introspect of Buxmont, Ltd
Colmar, Pennsylvania, United States
Clinical Neurosciences Solutions, Inc.
Memphis, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Radiant Research
Murray, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Northbrooke Research Center
Deer Brown, Wisconsin, United States
Countries
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Other Identifiers
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CX157-201
Identifier Type: -
Identifier Source: org_study_id