Efficacy Study of CLR3001 in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158547
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : February 4, 2015
University Health Network, Toronto
Information provided by (Responsible Party):
Clera Inc.

Brief Summary:
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 or disease

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

Study Type : Observational
Actual Enrollment : 86 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy using Hamilton Rating Scale for Depression [ Time Frame: Weeks 2 to 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158547

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Clera Inc.
University Health Network, Toronto
Principal Investigator: Sidney Kennedy, M.D. University Health Network, Toronto

Responsible Party: Clera Inc. Identifier: NCT01158547     History of Changes
Other Study ID Numbers: CLR3001
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

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