Ketamine augmentation of (meaning addition to) ECT to improve outcomes in depression.

Phase 1

• Conditions: Depressive disorder requiring treatment with electroconvulsive treatment (ECT); MedDRA version: 14.1 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-005476-41-GB
• Lead Sponsor: Manchester Mental Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Patient 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 disorder mood disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI) 3.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; 4.Verbal IQ = 85, sufficiently fluent in English to validly complete neuropsychological testing; 5.Capacity to give informed consent; 6.Willing to undertake neuropsychological testing as part of the study. Healthy control inclusion criteria: 1.Aged 18 years or more; 2.Currently psychiatrically well, confirmed through MINI interview and no current psychotropic medication; 3.In good physical health.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patient 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). Control exclusion Criteria: 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified