Trial | NCT01246908  Report issue

Title

Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cx157 ...

  • Study Participants

    360
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.
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 Started
Nov 30
2010
Primary Completion
May 31
2012
Study Completion
May 31
2012
Last Update
Jul 10
2012
Estimate

Drug Placebo

Placebo administered twice per day for six weeks.

  • Other names: Sugar Pill

Drug CX157 (TriRima)

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

CX157 (TriRima) Experimental

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

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted