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Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression (CX157-201)

Primary Purpose

Treatment Resistant Depression

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

CX157 (TriRima)

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring TRD

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Synergy Escondido
Synergy Clinical Research Center
Excell Research
Pacific Clinical Research
Gulfcoast Clinical Research Center
Clinical Neuroscience Solutions, Inc.
The Segal Institute of Clinical Research
Clinical Neuroscience Solutions, Inc.
University of South Florida College of Medicine Psychiatry Center
Stedman Clinical Trials
Kolin Research Group
Atlanta Institute of Medicine and Research
Nathan Shapira, MD, Ph.D
McLean Hospital
AccelRx Research
Eastside Comprehensive Medical Center
Richard H. Weisler, M.D. and Associates
NorthCoast Clinical Trials, Inc.
Patient Priority Clinical Sites, LLC
North Star Medical Research, LLC
Oregon Center for Clinical Investigations, Inc
Summitt Research Network (Oregon)
Introspect of Buxmont, Ltd
Clinical Neurosciences Solutions, Inc.
Community Clinical Research, Inc.
FutureSearch Trials of Dallas
Radiant Research
Northwest Clinical Research Center
Summit Research Network (Seattle) LLC
Northbrooke Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CX157 (TriRima)

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)

The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.

Secondary Outcome Measures

Severity of illness (CGI-S);

To measure severity of depression

Global Improvement (CGI-I)

To measure overall improvment.

Hospital Anxiety Depression Rating Scale (HADS)

To measure symptoms of depression

Full Information

NCT ID

NCT01246908

First Posted

November 2, 2010

Last Updated

July 8, 2012

Sponsor

CeNeRx BioPharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01246908

Brief Title

Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CeNeRx BioPharma Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

Keywords

TRD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CX157 (TriRima)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

Placebo administered twice per day for six weeks.

Intervention Type

Drug

Intervention Name(s)

CX157 (TriRima)

Intervention Description

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

Primary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale (MADRS)

Description

The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.

Time Frame

Over six weeks of study treatment

Secondary Outcome Measure Information:

Title

Severity of illness (CGI-S);

Description

To measure severity of depression

Time Frame

Over six weeks of treatment with study drug.

Title

Global Improvement (CGI-I)

Description

To measure overall improvment.

Time Frame

Over six weeks of treatment

Title

Hospital Anxiety Depression Rating Scale (HADS)

Description

To measure symptoms of depression

Time Frame

over six weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: