Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
Completed · Phase 1
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT02289248
- Run by
- Yale University
- People needed
- 16
- Starts
- 2015-02-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-03-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Connecticut Mental Health Center — New Haven, Connecticut, United States
- Yale Psychiatric Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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