A Study of CX157 (TriRima) for the Treatment of Depression

NCT00739908 | Completed Phase 2 Results DMC

• 1 other identifier: CX157-200
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.

Conditions

Major Depressive Disorder

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

• Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)

  The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD \[Montgomery, 1979\]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.

  Randomization and study end (Week 6).

Secondary Outcomes (6)

• Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate

  Week 6 or the last available post treatment result (LOCF)

• Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate

  Week 6 or the last available post treatment result (LOCF)

• The Hospital Anxiety and Depression Scale (HADS)

  Randomization and Week 6 or the last available post treatment result (LOCF)

• Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)

  Randomization and Week 6 or the last available post treatment result (LOCF)

• Clinical Global Impression - Improvement of Illness (CGI-I)

  Week 6 or the last available post treatment result (LOCF)

Study Arms (2)

CX157 (TriRima)

EXPERIMENTAL

Drug: CX157 (TriRima)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CX157 (TriRima) DRUG

Six capsules administered three times a day for six weeks.

CX157 (TriRima)

Placebo DRUG

Six capsules administered three times a day for six weeks.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female = 18 years of age and \<60 years
• Able to read, understand, converse in English
• Willing to comply with diet restrictions, concomitant medication restrictions, \& all study requirements
• Good general health as ascertained by:Medical history, Physical exam, Supine \& standing vital signs, Clinical lab evaluations, 12-lead Electrocardiogram (ECG)
• Diagnosis of MDD;
• A total score =\>40 on the IDS-SR30 assessed via IVRS at Screening and Randomization

You may not qualify if:

• Subject's current MDD episode is \>2 years
• History of Substance Use Disorder at Screening or 12 months prior (except for nicotine)
• Current diagnosis of Obsessive-Compulsive Disorder;
• Panic Disorder or Post-Traumatic Stress Disorder;
• Anorexia nervosa, Bulimia nervosa, or eating disorder not otherwise specified;
• Any Axis I Disorder clinically predominant to their MDD (within 6 mo);
• Presence of psychotic features with current depressive episode;
• Antisocial or Borderline Personality Disorder
• At risk for suicide
• Lack of response to \>2 trials of adequate dose \& duration of antidepressants of different mechanistic classes
• Electroconvulsive therapy within 1 year of Screening
• Subject has taken any psychoactive drug within 2 weeks of Randomization
• History of cardiac abnormalities including abnormal vital sign measurements
• Clinically significant abnormal ECG at Screening
• History within past 2 years of: Significant head trauma;

Sponsors & Collaborators

• CeNeRx BioPharma Inc.: lead

Study Sites (14)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

Southwestern Research, Inc.

Beverly Hills, California, United States

Location

The George Washington University

Washington D.C., District of Columbia, United States

Location

Irving S. Kolin, M.D.

Winter Park, Florida, 32789, United States

Location

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, United States

Location

McLean Hospital

Belmont, Massachusetts, United States

Location

CRI Worldwide, LLC

Clementon, New Jersey, United States

Location

Fieve Clinical Services

New York, New York, United States

Location

Richard H. Weisler, M.D., P.A.

Raleigh, North Carolina, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Location

FutureSearch Trials

Austin, Texas, 78756, United States

Location

Summit Research Network (Seattle), LLC

Seattle, Washington, United States

Location

Northbrooke Research Center

Brown Deer, Wisconsin, United States

Location

Related Publications (1)

• Targum SD. Early symptomatic improvement affects treatment outcome in a study of major depressive disorder. J Psychiatr Res. 2017 Dec;95:276-281. doi: 10.1016/j.jpsychires.2017.09.009. Epub 2017 Sep 8.

  PMID: 28926793 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

CX157; Sugars

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Subjects were asked to take 6 capsules 3 times a day for 6 weeks. Non-adherence with the study medication was high based on the population PK data. This likely contributed to the results in CX157 treatment group.

Results Point of Contact

• Title: Mahnaz Asgharnejad, Pharm.D.; Daniel Burch, M.D.
• Organization: CeNeRx BioPharma Inc.

masgharnejad@cenerx.com; danburch@cenerx.com

(919) 655 1435; (919) 674 6041

Study Officials

• Daniel Burch, MD

  CeNeRx BioPharma Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 20, 2008
• First Posted: August 22, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 27, 2012
• Results First Posted: June 27, 2012

Record last verified: 2012-06

Locations

US (14)