DepressionNCT01158547
Efficacy Study of CLR3001 in Depression
An observational study of Depression, run by Clera Inc. at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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- Persons who had previously withdrawn from this study or previous study investigating CLR3001.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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
CLR3001 is thought to work by helping the body's natural responses overcome depression.
- Conditions
- Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy using Hamilton Rating Scale for Depression
Measured: Weeks 2 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clera Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Sidney Kennedy, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158547
- Sponsor's protocol ID
- CLR3001
- Status last verified
- Feb 2015
- First submitted
- 6 Jul 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Placebo Controlled, Double-Blind, Randomized Parallel Group Study to Evaluate the Efficacy of Treatment With CLR3001 in Depression
- ClinicalTrials.gov ID
- NCT01158547
- Acronym / sponsor ID
- CLR3001
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Clera Inc.University, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Apr 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
CLR3001 is thought to work by helping the body's natural responses overcome depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy using Hamilton Rating Scale for Depression
Time frame: Weeks 2 to 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidney Kennedy, M.D. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Clera Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy using Hamilton Rating Scale for Depression (time frame: Weeks 2 to 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015; AzTrials last refreshed its copy on 6 Nov 2026.