Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

— CX157-201  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246908
• Other study ID #: CX157-201
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2010
• Last updated: July 8, 2012
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: CeNeRx BioPharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• Placebo
Placebo administered twice per day for six weeks.
• CX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	NorthCoast Clinical Trials, Inc.	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	McLean Hospital	Belmont	Massachusetts
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Introspect of Buxmont, Ltd	Colmar	Pennsylvania
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Northbrooke Research Center	Deer Brown	Wisconsin
United States	Synergy Escondido	Escondido	California
United States	AccelRx Research	Fall River	Massachusetts
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Clinical Neurosciences Solutions, Inc.	Memphis	Tennessee
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Radiant Research	Murray	Utah
United States	Synergy Clinical Research Center	National City	California
United States	The Segal Institute of Clinical Research	North Miami	Florida
United States	Eastside Comprehensive Medical Center	NYC	New York
United States	Excell Research	Oceanside	California
United States	Pacific Clinical Research	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Oregon Center for Clinical Investigations, Inc	Portland	Oregon
United States	Summitt Research Network (Oregon)	Portland	Oregon
United States	Richard H. Weisler, M.D. and Associates	Raleigh	North Carolina
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Nathan Shapira, MD, Ph.D	Smyrna	Georgia
United States	Stedman Clinical Trials	Tampa	Florida
United States	University of South Florida College of Medicine Psychiatry Center	Tampa	Florida
United States	Kolin Research Group	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CeNeRx BioPharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Severity of illness (CGI-S);	To measure severity of depression	Over six weeks of treatment with study drug.	No
Secondary	Global Improvement (CGI-I)	To measure overall improvment.	Over six weeks of treatment	No
Secondary	Hospital Anxiety Depression Rating Scale (HADS)	To measure symptoms of depression	over six weeks of treatment	No