Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289248
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
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
 (submitted: November 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2014)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
Change in MADRS from baseline through week eight using a random effects model
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
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Ketamine
    Subjects will undergo a twice weekly two week course of IV infusions of ketamine
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    Subjects will undergo twice weekly CBT for a total of 8 weeks
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:
  • Drug: Ketamine
  • Behavioral: Cognitive Behavioral Therapy (CBT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2017)
16
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2014)
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:

  • suffering from a depressive episode (DSM 5; either Major Depressive Disorder or Bipolar Disorder) and having failed one or more standard antidepressant treatments during the current episode;
  • Age 18-65;
  • Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to study entry.

Exclusion Criteria:

  • Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening;
  • Active suicidal thoughts with a plan; current or recent (<6 months ago) substance use disorder;
  • Non-affective psychosis (such as schizophrenia or schizoaffective disorder);
  • Pregnancy or breastfeeding;
  • Inability to speak English fluently;
  • A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results;
  • A history of CBT treatment in the past 12 months;
  • Dementia;
  • Delirium;
  • Any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in CBT.
  • Untreated hypertension as defined by a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements.
  • Recent myocardial infarction (within one year)
  • Syncopal event within the past year.
  • Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
  • Angina pectoris.
  • Heart rate <50 or >105 beats per minute at screening

Females are eligible provided they meet criteria A or B below:

  1. Non-childbearing potential: e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening; or
  2. Childbearing potential, and meets the following criteria:

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Samuel Wilkinson, MD Yale University
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