Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression (CX157-201)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CeNeRx BioPharma Inc.
ClinicalTrials.gov Identifier:
NCT01246908
First received: November 2, 2010
Last updated: July 8, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Treatment Resistant Depression
Drug: Placebo
Drug: CX157 (TriRima)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CeNeRx BioPharma Inc.:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Over six weeks of study treatment ] [ Designated as safety issue: No ]
    The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.


Secondary Outcome Measures:
  • Severity of illness (CGI-S); [ Time Frame: Over six weeks of treatment with study drug. ] [ Designated as safety issue: No ]
    To measure severity of depression

  • Global Improvement (CGI-I) [ Time Frame: Over six weeks of treatment ] [ Designated as safety issue: No ]
    To measure overall improvment.

  • Hospital Anxiety Depression Rating Scale (HADS) [ Time Frame: over six weeks of treatment ] [ Designated as safety issue: No ]
    To measure symptoms of depression


Enrollment: 360
Study Start Date: November 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CX157 (TriRima)
CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)
Drug: CX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
Other Name: CX157 (TriRima)
Placebo Comparator: Placebo Drug: Placebo
Placebo administered twice per day for six weeks.
Other Name: Sugar Pill

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 20 to 65 years of age
  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:

  1. Major depressive episode greater than five years
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246908

  Show 30 Study Locations
Sponsors and Collaborators
CeNeRx BioPharma Inc.
Investigators
Principal Investigator: Alan Yeo, MD Summitt Research Network - Oregon
Principal Investigator: Ram Shrivastava, MD Eastside Comprehensive Medical Center
Principal Investigator: Angelo Sambunaris, M.D. Atlanta Institute of Medicine and Research
Principal Investigator: Bijan Bastani, M.D. NorthCoast Clinical Trials
Principal Investigator: Mary Stedman, M.D. Stedman Clinical Trials
Principal Investigator: Richard Weisler, M.D. Richard H. Weisler, M.D. and Associates
Principal Investigator: Mark Joyce, M.D. Clinical Neuroscience Solutions, Inc.
Principal Investigator: Fares Arguello, MD Radiant Research
Principal Investigator: Valerie Arnold, MD Clinical Neurosciences Solutions, Inc.
Principal Investigator: Arif Khan, MD Northwest Clinical Research Center
Principal Investigator: Irving Kolin, MD Kolin Research Group
Principal Investigator: Jelena Kunovac, MD Excell Research
Principal Investigator: Jerry Steiert, MD Summit Research Network (Seattle) LLC
Principal Investigator: Lorena Wallhauser, MD Patient Priority Clinical Sites, LLC
Principal Investigator: Mohammed Bari, MD Synergy Clinical Research Center
Principal Investigator: Prakash Bhatia, MD Synergy Escondido
Principal Investigator: Michael Downing, MD FutureSearch Trials of Dallas
Principal Investigator: David Brown, MD Community Clinical Research, Inc.
Principal Investigator: Rosario Hidalgo, MD University of South Florida College of Medicine Psychiatry Center
Principal Investigator: Alec Bodkin, MD Mclean Hospital
Principal Investigator: Russell Pet, MD AccelRx Research
Principal Investigator: Beal Essink, M.D. Oregon Center for Clinical Investigations, Inc
Principal Investigator: Scott Segal, M.D. The Segal Institute of Clinical Research
Principal Investigator: Jeffrey Simon, M.D. Northbrooke Research Center
Principal Investigator: Charmaine Semeniuk, M.D. Pacific Clinical Research
Principal Investigator: John Prater, M.D. Gulfcoast Clinical Research Center
Principal Investigator: Mark Woyshville, M.D. North Star Medical Research LLC
Principal Investigator: Nathan Shapira, MD, Ph.D Carman Research
Principal Investigator: Robert Molpus, MD Clinical Neuroscience Solutions, Inc.
  More Information

No publications provided

Responsible Party: CeNeRx BioPharma Inc.
ClinicalTrials.gov Identifier: NCT01246908     History of Changes
Other Study ID Numbers: CX157-201
Study First Received: November 2, 2010
Last Updated: July 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CeNeRx BioPharma Inc.:
TRD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014