Ketamine augmentation of ECT to improve outcomes... — Clinical Trial Details

Participants

Ages

18 – ?

Sexes

Male & Female

BMI

Psychosis History

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).

Company

Product

Legal

Ketamine augmentation of ECT to improve outcomes in depression

Detailed Description

Study Arms & Interventions

Ketamine + ECT

Interventions

Saline + ECT

Interventions

Locations

Participants

Inclusion Criteria

Exclusion Criteria

Study Details