Status:
COMPLETED
Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
Lead Sponsor:
Yale University
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 CB...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02289248
Start Date
February 1 2015
End Date
October 1 2016
Last Update
March 1 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
2
Yale Psychiatric Hospital
New Haven, Connecticut, United States, 06519