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

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment Resistant Depression
• Intervention / Treatment: Drug: CX157 (TriRima); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • Synergy Escondido
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oceanside, California, United States, 92056
      • Excell Research
    • Orange, California, United States, 92868
      • Pacific Clinical Research
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • North Miami, Florida, United States, 33161
      • The Segal Institute of Clinical Research
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33163
      • University of South Florida College of Medicine Psychiatry Center
    • Winter Park, Florida, United States, 32789
      • Kolin Research Group
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine and Research
    • Smyrna, Georgia, United States, 30080
      • Nathan Shapira, MD, Ph.D
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Fall River, Massachusetts, United States, 02721
      • AccelRx Research
  • New York
    • NYC, New York, United States, 10021
      • Eastside Comprehensive Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Richard H. Weisler, M.D. and Associates
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • NorthCoast Clinical Trials, Inc.
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Center for Clinical Investigations, Inc
    • Portland, Oregon, United States, 97210
      • Summitt Research Network (Oregon)
  • Pennsylvania
    • Colmar, Pennsylvania, United States, 18915
      • Introspect of Buxmont, Ltd
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neurosciences Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc
  • Wisconsin
    • Deer Brown, Wisconsin, United States, 53223
      • Northbrooke Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo administered twice per day for six weeks.; Other Names: Sugar Pill
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)	The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.	Over six weeks of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of illness (CGI-S);	To measure severity of depression	Over six weeks of treatment with study drug.
Global Improvement (CGI-I)	To measure overall improvment.	Over six weeks of treatment
Hospital Anxiety Depression Rating Scale (HADS)	To measure symptoms of depression	over six weeks of treatment

Collaborators and Investigators

• Sponsor: 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 8, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: TRD
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: CX157-201