Efficacy Study of CLR3001 in Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Clera Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by:
Clera Inc.
ClinicalTrials.gov Identifier:
NCT01158547
First received: July 6, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to assess the ability of CLR3001 to reverse depressive symptoms relatively quickly in adult patients with major depressive disorder (MDD).


Condition
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Placebo Controlled, Double-Blind, Randomized Parallel Group Study to Evaluate the Efficacy of Treatment With CLR3001 in Depression

Further study details as provided by Clera Inc.:

Primary Outcome Measures:
  • Efficacy using Hamilton Rating Scale for Depression [ Time Frame: Weeks 2 to 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Detailed Description:

CLR3001 is thought to work by helping the body's natural responses overcome depression.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Male or female out-subjects 18-65 years.
  • Single episode or recurrent MDD (to a maximum of 5 prior episodes).
  • No current therapy for depression as per washout instructions.
  • Able to provide written informed consent.
  • Meet criteria for MDD with current MDE through MINI questionnaire.
  • Meet criteria for MDD with current MDE, as defined by DSM-IV TR.
  • HAMD-17 score ≥ 14 at screening (visit 1) and baseline (Visit 2; Randomization).
  • Able to understand and complete questionnaires, and communicate with the investigator and study coordinator.
  • Judged to be reliable to keep all appointments and procedures required by the protocol.
  • Female subjects of childbearing potential (who are not at least 2 years postmenopausal or surgically sterile or totally abstinent) must be using a reliable, medically acceptable form of contraception and must agree to continue such use throughout the duration of the study. Reliable forms of contraception include oral, implanted, transdermal or injected contraceptives, intrauterine devices, and adequate double barrier methods including use of spermicide. Partner's vasectomy is also an acceptable contraceptive regimen.

Exclusion Criteria:

  • Investigators and immediate family members.
  • Treatment within the last 90 days with a drug that had not received regulatory approval at the time of study entry.
  • Persons who had previously withdrawn from this study or previous study investigating CLR3001.
  • A primary diagnosis of Panic Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder within the past year.
  • The presence of an Axis II disorder, which, in the opinion of the investigator, would interfere with compliance in the study.
  • History of active substance dependence within the last half-year, excluding nicotine and coffee, or active substance abuse that may interfere with the outcome of the study.
  • Acute suicidal ideation or risk, ≥3 on HAMD-17 suicide item.
  • Fall in HAMD-17 score greater than 20% between Visit 1 and Visit 2.
  • Serious concomitant diseases such as cancer, serious metabolic (e.g. Insulin dependent diabetes), renal, cardiac, thyroid, immunological, neurological or other significant disease or laboratory abnormality (hematology, blood chemistry, ECG), or treatment for medical conditions which may interact with CLR3001.
  • Women who are pregnant or breast-feeding, or men or women who plan to
  • Infirmities or living in an area limiting participation in the study or compliance with study procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158547

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Franca Placenza    416 340-4800 ext 8839    franca.placenza@uhn.on.ca   
Contact: Sakina Rizvi    416 340-3466    Sakina.Rizvi@uhn.on.ca   
Principal Investigator: Sidney Kennedy, M.D.         
Sponsors and Collaborators
Clera Inc.
University Health Network, Toronto
Investigators
Principal Investigator: Sidney Kennedy, M.D. University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Bob Seeman, CEO, Clera Inc.
ClinicalTrials.gov Identifier: NCT01158547     History of Changes
Other Study ID Numbers: CLR3001
Study First Received: July 6, 2010
Last Updated: June 21, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014