Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
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ClinicalTrials.gov Identifier: NCT02289248 |
Recruitment Status :
Completed
First Posted : November 13, 2014
Last Update Posted : March 1, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | November 4, 2014 | |||
First Posted Date ICMJE | November 13, 2014 | |||
Last Update Posted Date | March 1, 2017 | |||
Study Start Date ICMJE | February 2015 | |||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Extinction Learning Task performance [ Time Frame: 24 hours Post ketamine infusion ] Hopkins Verbal Learning Test and extinction learning tasks will be administered both one week before and 24-hours after the first ketamine infusion and the change in scores compared.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] Change in MADRS from baseline through week eight using a random effects model
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine | |||
Official Title ICMJE | Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine | |||
Brief Summary | Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks. | |||
Detailed Description | Twelve subjects with current diagnosis of depressive episode will be recruited to undergo a brief course of 4 intravenous infusions of ketamine, given twice weekly for two weeks in combination with CBT, given twice weekly. The CBT course will be 16 total sessions (given over 8 weeks), will begin the day following the initial ketamine infusion, and will be performed by a therapist who has successfully completed extensive training at the Beck Institute for Cognitive Therapy and Research and has experience with similar studies. Homework assignments will include thought records and activity charts which are used in standard practice to facilitate CBT interventions. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Depression | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Ketamine/CBT Group
Subjects will undergo 2 week course of 4 intravenous infusions of ketamine (given twice weekly for two weeks) in combination with twice weekly cognitive behavioral therapy for a total of 8 weeks.
Interventions:
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
16 | |||
Original Estimated Enrollment ICMJE |
12 | |||
Actual Study Completion Date ICMJE | October 2016 | |||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Females are eligible provided they meet criteria A or B below:
i. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent. ii. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at enrollment prior to receiving study treatment. iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02289248 | |||
Other Study ID Numbers ICMJE | 1501015171 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Yale University | |||
Study Sponsor ICMJE | Yale University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Yale University | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |