A Study of Ketamine as an Antidepressant
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ClinicalTrials.gov Identifier: NCT01441505 |
Recruitment Status
: Unknown
Verified February 2013 by Colleen Loo, The University of New South Wales.
Recruitment status was: Recruiting
First Posted
: September 27, 2011
Last Update Posted
: February 22, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | September 16, 2011 | |||
First Posted Date ICMJE | September 27, 2011 | |||
Last Update Posted Date | February 22, 2013 | |||
Study Start Date ICMJE | September 2011 | |||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline on depression rating scales [ Time Frame: Before, 4 hours after, and 24 hours after ketamine session ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01441505 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Psychiatric side effects (BPRS, CADSS) and memory tests [ Time Frame: Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases. ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Ketamine as an Antidepressant | |||
Official Title ICMJE | A Study of Ketamine as an Antidepressant | |||
Brief Summary | Recently, interest has emerged in the use of ketamine as an antidepressant. Recent placebo-controlled clinical trials administering a single dose and an open label trial giving repeated doses shown that ketamine is markedly superior to placebo at reducing depression, including in treatment-resistant patients, and that its antidepressant effects have a very rapid onset. This clinical study consists of two phases. In Phase I, participants who satisfy inclusion criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II, they will receive repeated sessions of ketamine at variable doses over three weeks. During both phases, mood, psychiatric, and neuropsychological outcomes will be measured. |
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Detailed Description | This clinical study consists of two phases. In Phase I, participants will receive variable doses of intravenous, intramuscular, or subcutaneous ketamine (0.1-0.5mg/kg) or placebo (saline, or 0.01mg/kg midazolam) weekly for up to 6 consecutive weeks. Prior to receiving ketamine/placebo, participants' mood and psychiatric symptoms will be assessed. Once they have received their treatment, mood, psychiatric side effects, ketamine blood levels, heart rate, blood pressure and biomarkers will be assessed. Mood and cognitive performance be assessed again after 4 hours. Finally, mood will also be assessed the next day. Some participants may be eligible to continue to Phase II. In this phase, participants will receive doses of ketamine approximately weekly for up to 6 months. During this phase, participants' mood, psychiatric, biomarkers and cognitive outcomes will be assessed. The purpose of the trial is to investigate the antidepressant and safety effects of using ketamine as a treatment in depression. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Major Depressive Episode | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
42 | |||
Original Estimated Enrollment ICMJE |
28 | |||
Estimated Study Completion Date | December 2014 | |||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01441505 | |||
Other Study ID Numbers ICMJE | HREC 10409 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Colleen Loo, The University of New South Wales | |||
Study Sponsor ICMJE | The University of New South Wales | |||
Collaborators ICMJE | Wesley Hospital, Kogarah | |||
Investigators ICMJE |
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PRS Account | The University of New South Wales | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |