Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
- Conditions
- Treatment Resistant Depression
- Interventions
- Drug: Placebo
- Registration Number
- NCT01246908
- Lead Sponsor
- CeNeRx BioPharma Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CX157 (TriRima) CX157 (TriRima) CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI) Placebo Placebo -
- Primary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale (MADRS) Over six weeks of study treatment The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.
- Secondary Outcome Measures
Name Time Method Severity of illness (CGI-S); Over six weeks of treatment with study drug. To measure severity of depression
Global Improvement (CGI-I) Over six weeks of treatment To measure overall improvment.
Hospital Anxiety Depression Rating Scale (HADS) over six weeks of treatment To measure symptoms of depression
Trial Locations
- Locations (29)
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Richard H. Weisler, M.D. and Associates
🇺🇸Raleigh, North Carolina, United States
University of South Florida College of Medicine Psychiatry Center
🇺🇸Tampa, Florida, United States
Synergy Escondido
🇺🇸Escondido, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Pacific Clinical Research
🇺🇸Orange, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
The Segal Institute of Clinical Research
🇺🇸North Miami, Florida, United States
Atlanta Institute of Medicine and Research
🇺🇸Atlanta, Georgia, United States
Kolin Research Group
🇺🇸Winter Park, Florida, United States
AccelRx Research
🇺🇸Fall River, Massachusetts, United States
Nathan Shapira, MD, Ph.D
🇺🇸Smyrna, Georgia, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Eastside Comprehensive Medical Center
🇺🇸NYC, New York, United States
NorthCoast Clinical Trials, Inc.
🇺🇸Beachwood, Ohio, United States
Patient Priority Clinical Sites, LLC
🇺🇸Cincinnati, Ohio, United States
Summitt Research Network (Oregon)
🇺🇸Portland, Oregon, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Introspect of Buxmont, Ltd
🇺🇸Colmar, Pennsylvania, United States
Oregon Center for Clinical Investigations, Inc
🇺🇸Portland, Oregon, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Clinical Neurosciences Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Northbrooke Research Center
🇺🇸Deer Brown, Wisconsin, United States
Radiant Research
🇺🇸Murray, Utah, United States