Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

NCT01246908 | Completed Phase 2

• 1 other identifier: CX157-201
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Treatment Resistant Depression

Keywords

TRD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of illness (CGI-S);

  Over six weeks of treatment with study drug.

• Global Improvement (CGI-I)

  Over six weeks of treatment

• Hospital Anxiety Depression Rating Scale (HADS)

  over six weeks of treatment

Study Arms (2)

CX157 (TriRima)

EXPERIMENTAL

CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)

Drug: CX157 (TriRima)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo administered twice per day for six weeks.

Also known as: Sugar Pill

Placebo

CX157 (TriRima) DRUG

One tablet administered twice per day (total daily dose of 250 mg) for six weeks.

CX157 (TriRima)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 20 to 65 years of age
• Able to read, understand and converse in English and provide written, dated informed consent
• Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD)
• Females on acceptable method of contraception

You may not qualify if:

• Major depressive episode greater than five years
• A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months
• Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD
• A history of schizophrenia or schizoaffective disorders
• A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years
• A history of Antisocial Personality Disorder or Borderline Personality Disorder
• Recent suicidal behavior and is at risk of such behavior during the course of the study
• Electroconvulsive therapy (ECT) within the past five years
• Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression
• Vagus Nerve Stimulation (VNS) at any time
• Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug
• Significant abnormality on the screening physical examination
• Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris
• 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
• A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months

Sponsors & Collaborators

• CeNeRx BioPharma Inc.: lead

Study Sites (30)

Synergy Escondido

Escondido, California, 92025, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Pacific Clinical Research

Orange, California, 92868, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

The Segal Institute of Clinical Research

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

University of South Florida College of Medicine Psychiatry Center

Tampa, Florida, 33163, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Kolin Research Group

Winter Park, Florida, 32789, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

Nathan Shapira, MD, Ph.D

Smyrna, Georgia, 30080, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

AccelRx Research

Fall River, Massachusetts, 02721, United States

Location

Eastside Comprehensive Medical Center

New York, New York, 10021, United States

Location

Richard H. Weisler, M.D. and Associates

Raleigh, North Carolina, 27609, United States

Location

NorthCoast Clinical Trials, Inc.

Beachwood, Ohio, 44122, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Oregon Center for Clinical Investigations, Inc

Portland, Oregon, 97210, United States

Location

Summitt Research Network (Oregon)

Portland, Oregon, 97210, United States

Location

Introspect of Buxmont, Ltd

Colmar, Pennsylvania, 18915, United States

Location

Clinical Neurosciences Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Radiant Research

Murray, Utah, 84123, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Northbrooke Research Center

Deer Brown, Wisconsin, 53223, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Sugars; CX157

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

US (30)