Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression (CX157-201)
This study has been completed.
Sponsor:
CeNeRx BioPharma Inc.
Information provided by (Responsible Party):
CeNeRx BioPharma Inc.
ClinicalTrials.gov Identifier:
NCT01246908
First received: November 2, 2010
Last updated: July 8, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Treatment Resistant Depression |
Drug: Placebo Drug: CX157 (TriRima) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by CeNeRx BioPharma Inc.:
Primary Outcome Measures:
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Over six weeks of study treatment ] [ Designated as safety issue: No ]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); [ Time Frame: Over six weeks of treatment with study drug. ] [ Designated as safety issue: No ]To measure severity of depression
- Global Improvement (CGI-I) [ Time Frame: Over six weeks of treatment ] [ Designated as safety issue: No ]To measure overall improvment.
- Hospital Anxiety Depression Rating Scale (HADS) [ Time Frame: over six weeks of treatment ] [ Designated as safety issue: No ]To measure symptoms of depression
| Enrollment: | 360 |
| Study Start Date: | November 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Name: CX157 (TriRima)
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo administered twice per day for six weeks.
Other Name: Sugar Pill
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246908
Show 30 Study Locations
Show 30 Study LocationsSponsors and Collaborators
CeNeRx BioPharma Inc.
Investigators
| 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. |
More Information
No publications provided
| Responsible Party: | CeNeRx BioPharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01246908 History of Changes |
| Other Study ID Numbers: | CX157-201 |
| Study First Received: | November 2, 2010 |
| Last Updated: | July 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CeNeRx BioPharma Inc.:
|
TRD |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013