Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT01246908

Run by

CeNeRx BioPharma Inc.

People needed

360

Starts

2010-11-01

Expected to finish

2012-05-01

Last updated by the study team

2012-07-10

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening
• Participation in an investigational study in the past one month
• A positive screening urine test for drugs of abuse
• Female subject who is pregnant or lactating

Where it is running

• 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

Full record on ClinicalTrials.gov

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