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

Sponsor
CeNeRx BioPharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01246908
Collaborator
(none)
360
Enrollment
30
Locations
2
Arms
18
Duration (Months)
12
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: CX157 (TriRima)
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.
Placebo Comparator: Placebo

Drug: Placebo
Placebo administered twice per day for six weeks.
Other Names:
  • Sugar Pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Montgomery Asberg Depression Rating Scale (MADRS) [Over six weeks of study treatment]

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

    Secondary Outcome Measures

    1. Severity of illness (CGI-S); [Over six weeks of treatment with study drug.]

      To measure severity of depression

    2. Global Improvement (CGI-I) [Over six weeks of treatment]

      To measure overall improvment.

    3. Hospital Anxiety Depression Rating Scale (HADS) [over six weeks of treatment]

      To measure symptoms of depression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Synergy Escondido Escondido California United States 92025
    2 Synergy Clinical Research Center National City California United States 91950
    3 Excell Research Oceanside California United States 92056
    4 Pacific Clinical Research Orange California United States 92868
    5 Gulfcoast Clinical Research Center Fort Myers Florida United States 33912
    6 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32216
    7 The Segal Institute of Clinical Research North Miami Florida United States 33161
    8 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32806
    9 University of South Florida College of Medicine Psychiatry Center Tampa Florida United States 33163
    10 Stedman Clinical Trials Tampa Florida United States 33613
    11 Kolin Research Group Winter Park Florida United States 32789
    12 Atlanta Institute of Medicine and Research Atlanta Georgia United States 30328
    13 Nathan Shapira, MD, Ph.D Smyrna Georgia United States 30080
    14 McLean Hospital Belmont Massachusetts United States 02478
    15 AccelRx Research Fall River Massachusetts United States 02721
    16 Eastside Comprehensive Medical Center NYC New York United States 10021
    17 Richard H. Weisler, M.D. and Associates Raleigh North Carolina United States 27609
    18 NorthCoast Clinical Trials, Inc. Beachwood Ohio United States 44122
    19 Patient Priority Clinical Sites, LLC Cincinnati Ohio United States 45215
    20 North Star Medical Research, LLC Middleburg Heights Ohio United States 44130
    21 Oregon Center for Clinical Investigations, Inc Portland Oregon United States 97210
    22 Summitt Research Network (Oregon) Portland Oregon United States 97210
    23 Introspect of Buxmont, Ltd Colmar Pennsylvania United States 18915
    24 Clinical Neurosciences Solutions, Inc. Memphis Tennessee United States 38119
    25 Community Clinical Research, Inc. Austin Texas United States 78754
    26 FutureSearch Trials of Dallas Dallas Texas United States 75231
    27 Radiant Research Murray Utah United States 84123
    28 Northwest Clinical Research Center Bellevue Washington United States 98007
    29 Summit Research Network (Seattle) LLC Seattle Washington United States 98104
    30 Northbrooke Research Center Deer Brown Wisconsin United States 53223

    Sponsors 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CeNeRx BioPharma Inc.
    ClinicalTrials.gov Identifier:
    NCT01246908
    Other Study ID Numbers:
    • CX157-201
    First Posted:
    Nov 24, 2010
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by CeNeRx BioPharma Inc.
    TRD
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Depressive Disorder, Treatment-Resistant

    Study Results

    No Results Posted as of Jul 10, 2012