Ketamine-ECT Study

Not Applicable

Completed

Conditions: Bipolar affective disorder, depression
Mental and Behavioural Disorders
Bipolar affective disorder, current episode mild or moderate depression

Registration Number: ISRCTN14689382

Lead Sponsor: Manchester Mental Health & Social Care Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 160

Inclusion Criteria

Patients:
1. Only patients who are referred by their consultant for ECT and who are patients of one of the following 5 participating Trusts will be able to take part: Manchester Mental Health & Social Care Trust, Northumberland, Tyne & Wear NHS Foundation Trust, Leeds & York Partnership NHS Foundation Trust, Greater Manchester West Mental Health NHS Foundation Trust and Pennine Care NHS Foundation Trust (added as of 13/11/2012)
2. Male or female aged 18 years and above
3. Current DSM-IV diagnosis of a major depressive episode, moderate or severe as part of unipolar or bipolar disorder mood disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI)
4. American Society of Anaesthesiologists (ASA) score (excluding mental health considerations in the scoring) of 1, 2 or stable 3, and judged as suitable to receive ketamine by an anaesthetist
5. Verbal IQ = 85, sufficiently fluent in English to validly complete neuropsychological testing
6. Capacity to give informed consent
7. Willing to undertake neuropsychological testing as part of the study.

Healthy control:
1. Aged 18 years or more
2. Currently psychiatrically well, confirmed through MINI interview and no current psychotropic medication
3. In good physical health
4. Male or female participants
5. Aged 18 years and above

Exclusion Criteria

Patients:
1. DSM-IV diagnosis of a primary psychotic or schizoaffective disorder, current primary obsessive compulsive disorder or anorexia nervosa
2. History of drug or alcohol dependence (DSM-IV criteria) within the last year
3. ECT in last 6 months (to avoid confounding the assessment of cognitive outcomes) or has previously received ECT in the current trial
4. Known hypersensitivity or contraindication to ketamine or excipients in the injection; including significant cardiovascular disease, uncontrolled hypertension, glaucoma, cirrhosis or significant liver impairment
5. Known hypersensitivity or contraindication to concomitant medications used for ECT: thiopentone (thiopental), propofol and suxamethonium or excipients in the injections
6. Evidence of organic brain disease including dementia, neurological illness or injury, or medical illness which may significantly affect neuropsychological function
7. Detained under the Mental Health Act (1983 as amended 2007) or unable to give informed consent
8. Pregnancy, or at risk of pregnancy and not taking adequate contraception, breastfeeding
9. Score = 24 on the Mini Mental State Examination (MMSE)
10. In the subgroup receiving MRI based investigation (fMRI, MRS and ASL) contraindication to MRI (eg metal implants or foreign bodies such as from a surgical implant, accident or injury).

Control:
1. Personal history of psychiatric disorder, as revealed by MINI interview
2. First degree family history of major psychiatric illness requiring treatment
3. Significant physical illness including organic brain disease, neurological illness or injury that could interfere with interpretation of results
4. Psychotropic medication or other medication that could interfere with interpretation of results
5. Score = 24 on the Mini Mental State Examination (MMSE)
6. In the subgroup receiving MRI based investigation (fMRI, MRS and ASL) contraindication to MRI (eg metal implants or foreign bodies such as from a surgical implant, accident or injury).