Depression. MedDRA version: 13.1 Level: PT Classification code 10014404 Term: Electroconvulsive therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 13.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA vers
Conditions
Interventions
Trade Name: Ketalar
Product Name: ketamine
Product Code: N/A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ketamine h
Sponsors
University of Aberdeen
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Between the ages of 18 and 75. - Diagnosed with depression and being referred for ECT. - American Society of Anesthesiologists (ASA) score of 1 or 2. - Patient receiving ECT on an informal basis (i.e. consenting to treatment and able to give informed consent). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pre-existing neurological disease or cognitive impairment - co-morbid psychiatric diagnoses - pre-existing severe hypertension - severe respiratory tract disease - major cardiovascular disease - pacemakers - significant cerebrovascular disorder or malformation - intracranial mass lesions - seizure disorder - intracranial electrode and clips - severe intra-ocular pathology - significant endocrine or metabolic disease - severe hematologic disease - severe fracture - not able to give consent - pregnancy - obesity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main research question is whether the use of ketamine as the anaesthetic for ECT treatment for depression improves the treatment outcome with respect to speed of response and reduction in side effects when compared to conventional anaesthesia.;Secondary Objective: The secondary objective is to assess whether the use of ketamine as the anaesthetic for ECT will reduce the cognitive impairments (anterograde memory) associated with ECT.;Primary end point(s): The primary outcome measure will be change in depressive symptoms after the fourth ECT treatment. This will be assessed by the change in MADRS and 17-item HDRS scores between start of treatment and this time point. By monitoring depressive symptoms we will be able to ascertain whether ketamine has any effect on the magnitude of symptom remission. | — |
Countries
United Kingdom
Outcome results
None listed