ISRCTN14689382Completed未知
Ketamine augmentation of electroconvulsive therapy to improve outcomes in depression
Manchester Mental Health & Social Care Trust (UK)0 sites160 target enrollmentStarted: July 30, 2012Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •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).
- •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).
Investigators
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