- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158547
Efficacy Study of CLR3001 in Depression
February 2, 2015 updated by: Clera Inc.
A Pilot Placebo Controlled, Double-Blind, Randomized Parallel Group Study to Evaluate the Efficacy of Treatment With CLR3001 in Depression
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).
Study Overview
Status
Completed
Conditions
Detailed Description
CLR3001 is thought to work by helping the body's natural responses overcome depression.
Study Type
Observational
Enrollment (Actual)
86
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
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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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
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy using Hamilton Rating Scale for Depression
Time Frame: Weeks 2 to 7
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Weeks 2 to 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sidney Kennedy, M.D., University Health Network, Toronto
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
April 1, 2010
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
July 6, 2010
First Submitted That Met QC Criteria
July 7, 2010
First Posted (ESTIMATE)
July 8, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLR3001
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.
Clinical Trials on Depression
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ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
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Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
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University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
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Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
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University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
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Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic