Clinical TrialDepressive DisordersKetamineCompleted

Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine

Single-group Phase I study (n=16): four IV ketamine infusions (twice weekly over 2 weeks) combined with 16 CBT sessions over 8 weeks for depressive episodes.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Twelve to sixteen subjects with current depressive episodes receive a course of four intravenous ketamine infusions administered twice weekly over two weeks combined with structured cognitive behavioural therapy beginning the day after the first infusion.

CBT comprises 16 sessions over eight weeks delivered by a Beck Institute-trained therapist; primary outcomes focus on antidepressant response and durability following ketamine.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine + CBT

experimental

Four IV ketamine infusions over 2 weeks combined with a 16-session CBT course over 8 weeks.

Interventions

  • Ketamine
    via IV• twice weekly• 4 doses total

    4 intravenous infusions given twice weekly over 2 weeks

  • Compound
    via Other• twice weekly• 16 doses total

    Cognitive Behavioral Therapy: 16 sessions over 8 weeks, begins day after first infusion; therapist trained at the Beck Institute

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2015-02-01
    End: 2016-10-01
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Connecticut Mental Health Center — New Haven, Connecticut, United States
Yale Psychiatric Hospital — New Haven, Connecticut, United States

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