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

July 8, 2012 updated by: CeNeRx BioPharma Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
        • Synergy Escondido
      • National City, California, United States, 91950
        • Synergy Clinical Research Center
      • Oceanside, California, United States, 92056
        • Excell Research
      • Orange, California, United States, 92868
        • Pacific Clinical Research
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions, Inc.
      • North Miami, Florida, United States, 33161
        • The Segal Institute of Clinical Research
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Tampa, Florida, United States, 33163
        • University of South Florida College of Medicine Psychiatry Center
      • Winter Park, Florida, United States, 32789
        • Kolin Research Group
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine and Research
      • Smyrna, Georgia, United States, 30080
        • Nathan Shapira, MD, Ph.D
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Mclean Hospital
      • Fall River, Massachusetts, United States, 02721
        • AccelRx Research
    • New York
      • NYC, New York, United States, 10021
        • Eastside Comprehensive Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, M.D. and Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • NorthCoast Clinical Trials, Inc.
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites, LLC
      • Middleburg Heights, Ohio, United States, 44130
        • North Star Medical Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Center for Clinical Investigations, Inc
      • Portland, Oregon, United States, 97210
        • Summitt Research Network (Oregon)
    • Pennsylvania
      • Colmar, Pennsylvania, United States, 18915
        • Introspect of Buxmont, Ltd
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neurosciences Solutions, Inc.
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
    • Utah
      • Murray, Utah, United States, 84123
        • Radiant Research
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc
    • Wisconsin
      • Deer Brown, Wisconsin, United States, 53223
        • Northbrooke Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo administered twice per day for six weeks.
Other Names:
  • Sugar Pill
Experimental: CX157 (TriRima)
CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)
Drug: CX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Over six weeks of study treatment
The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.
Over six weeks of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of illness (CGI-S);
Time Frame: Over six weeks of treatment with study drug.
To measure severity of depression
Over six weeks of treatment with study drug.
Global Improvement (CGI-I)
Time Frame: Over six weeks of treatment
To measure overall improvment.
Over six weeks of treatment
Hospital Anxiety Depression Rating Scale (HADS)
Time Frame: over six weeks of treatment
To measure symptoms of depression
over six weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CeNeRx BioPharma Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alan Yeo, MD, Summitt Research Network - Oregon
  • Principal Investigator: Ram Shrivastava, MD, Eastside Comprehensive Medical Center
  • Principal Investigator: Angelo Sambunaris, M.D., Atlanta Institute of Medicine and Research
  • Principal Investigator: Bijan Bastani, M.D., Northcoast Clinical Trials
  • Principal Investigator: Mary Stedman, M.D., Stedman Clinical Trials
  • Principal Investigator: Richard Weisler, M.D., Richard H. Weisler, M.D. and Associates
  • Principal Investigator: Mark Joyce, M.D., Clinical Neuroscience Solutions, Inc.
  • Principal Investigator: Fares Arguello, MD, Radiant Research
  • Principal Investigator: Valerie Arnold, MD, Clinical Neurosciences Solutions, Inc.
  • Principal Investigator: Arif Khan, MD, Northwest Clinical Research Center
  • Principal Investigator: Irving Kolin, MD, Kolin Research Group
  • Principal Investigator: Jelena Kunovac, MD, Excell Research
  • Principal Investigator: Jerry Steiert, MD, Summit Research Network (Seattle) Llc
  • Principal Investigator: Lorena Wallhauser, MD, Patient Priority Clinical Sites, LLC
  • Principal Investigator: Mohammed Bari, MD, Synergy Clinical Research Center
  • Principal Investigator: Prakash Bhatia, MD, Synergy Escondido
  • Principal Investigator: Michael Downing, MD, FutureSearch Trials of Dallas
  • Principal Investigator: David Brown, MD, Community Clinical Research, Inc.
  • Principal Investigator: Rosario Hidalgo, MD, University of South Florida College of Medicine Psychiatry Center
  • Principal Investigator: Alec Bodkin, MD, Mclean Hospital
  • Principal Investigator: Russell Pet, MD, AccelRx Research
  • Principal Investigator: Beal Essink, M.D., Oregon Center for Clinical Investigations, Inc
  • Principal Investigator: Scott Segal, M.D., The Segal Institute of Clinical Research
  • Principal Investigator: Jeffrey Simon, M.D., Northbrooke Research Center
  • Principal Investigator: Charmaine Semeniuk, M.D., Pacific Clinical Research
  • Principal Investigator: John Prater, M.D., Gulfcoast Clinical Research Center
  • Principal Investigator: Mark Woyshville, M.D., North Star Medical Research LLC
  • Principal Investigator: Nathan Shapira, MD, Ph.D, Carman Research
  • Principal Investigator: Robert Molpus, MD, Clinical Neuroscience Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CX157-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings