Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Ketamine augmentation of ECT to improve outcomes in depression

This double-blind, placebo-controlled trial (n=180) investigated the potential benefits of ketamine augmentation during electroconvulsive treatment (ECT) to improve outcomes in depression (MDD).

Target Enrollment
180 participants
Study Type
Phase IV interventional
Design
Randomized, single Blind

Detailed Description

Randomised, placebo-controlled, parallel-group trial (n=180) comparing intravenous ketamine (Ketalar) versus saline administered as a bolus during ECT in adults with depressive episodes; primary aims relate to cognitive outcomes and depression severity.

Primary cognitive endpoints include HVLT-R, AMI-SF and COWAT measured between baseline and end of ECT course; secondary outcomes include depression scales (MADRS, QIDS-SR), number of ECT treatments to remission, and mechanistic neuroimaging measures (fNIRS, fMRI, MRS, ASL).

Study Arms & Interventions

Ketamine + ECT

experimental

Ketalar (ketamine hydrochloride) intravenous bolus administered during ECT

Interventions

  • Ketamine
    via IV• during ECT

    Ketalar (ketamine hydrochloride) IV bolus; concentration 10 mg/ml; dose per protocol.

Saline + ECT

inactive

Normal saline placebo intravenous bolus administered during ECT

Interventions

  • Placebo
    via IV• during ECT

    Normal saline placebo; solution for injection/infusion.

Participants

Ages
18 – ?
Sexes
Male & Female

Inclusion Criteria

  • Patient inclusion criteria:
  • 1. Male or female aged 18 years and above.
  • 2. Current DSM-IV diagnosis of a major depressive episode, moderate or severe as part of unipolar or bipolar mood disorder diagnosed by the MINI.
  • 3. ASA score 1, 2 or stable 3 and judged suitable to receive ketamine by an anaesthetist.
  • 4. Verbal IQ ≥85 and sufficiently fluent in English to complete neuropsychological testing.
  • 5. Capacity to give informed consent and willing to undertake neuropsychological testing.
  • Healthy control inclusion criteria:
  • 1. Aged 18 years or more.
  • 2. Currently psychiatrically well confirmed through MINI and no current psychotropic medication.
  • 3. In good physical health.

Exclusion Criteria

  • Patient exclusion criteria:
  • 1. Primary psychotic or schizoaffective disorder, current primary OCD or anorexia nervosa.
  • 2. Drug or alcohol dependence within the last year (DSM-IV criteria).
  • 3. ECT in last 6 months or previously received ECT in the current trial.
  • 4. Known hypersensitivity or contraindication to ketamine or excipients; significant cardiovascular disease, uncontrolled hypertension, glaucoma, cirrhosis or significant liver impairment.
  • 5. Known hypersensitivity or contraindication to concomitant anaesthetic agents used for ECT (thiopentone/propofol, suxamethonium) or their excipients.
  • 6. Evidence of organic brain disease including dementia, neurological illness or injury, or medical illness likely to affect neuropsychological function.
  • 7. Detained under the Mental Health Act or unable to give informed consent.
  • 8. Pregnancy, at risk of pregnancy and not using adequate contraception, or breastfeeding.
  • 9. MMSE score ≤24.
  • 10. Contraindication to MRI for subgroup (eg metal implants) where applicable.
  • Control exclusion criteria:
  • 1. Personal history of psychiatric disorder as revealed by MINI.
  • 2. First-degree family history of major psychiatric illness requiring treatment (for controls).
  • 3. Significant physical illness including organic brain disease or neurological illness that could interfere with interpretation of results.
  • 4. Psychotropic medication or other medication that could interfere with interpretation of results.
  • 5. MMSE score ≤24.
  • 6. Contraindication to MRI for subgroup (eg metal implants).

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment180 participants
  • Timeline
    Start: 2012-01-25
    End: 2015-09-30
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

United Kingdom

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