Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2015-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment arm
Ketamine
Ketamine
Placebo arm
Placebo
Placebo
Interventions
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Ketamine
Placebo
Eligibility Criteria
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Inclusion Criteria
* an inadequate response to at least 2 adequate antidepressants
* MADRS ≥ 20
Patients will be excluded on the basis of:
* History of psychosis
* History of bipolar disorder
* Any unstable medical or neurologic condition
* Any Axis I disorder other than MDD judged to be primary presenting problem
* Planned major changes to psychotropic medication
* Significant risk of suicide
* Planned or probable use of ECT
* Age under 16 years, or 16-17 years without parental consent
* Substance abuse or dependence in previous 6 months
* Any history of abuse of ketamine or phencyclidine
* Contraindication to the use of ketamine
* Planned use of ketamine
* Women of childbearing potential not taking reliable contraception
* Likely non-compliance with trial treatment
* Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
16 Years
ALL
No
Sponsors
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University of Sydney
OTHER
The University of New South Wales
OTHER
Responsible Party
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Colleen Loo
Professor
Principal Investigators
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Colleen K Loo, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
University of New South Wales
Locations
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Brain & Mind Research Institute (BMRI), University of Sydney
Camperdown, New South Wales, Australia
Black Dog Institute, University of New South Wales
Sydney, New South Wales, Australia
Countries
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Other Identifiers
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HREC 15009
Identifier Type: -
Identifier Source: org_study_id
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