Ketamine for Depression Relapse Prevention Following ECT (KEEP-WELL)
Depression
About this trial
This is an interventional prevention trial for Depression focused on measuring ketamine, electroconvulsive therapy, glutamate
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years with unipolar major depressive disorder (DSM-IV)
- 24-item Hamilton Rating Scale for Depression (HRSD-24) score of ≥21
- Referred for ECT
For the randomised Phase 2, patients must have
- received a substantial course of ECT in Phase 1 (i.e. at least five sessions)
- achieved at least response criteria (i.e. ≥60% decrease from baseline HRSD-24 score and score ≤16 on two consecutive weekly ratings)
- have a nominated adult who can stay with them for 24-hours on out-patient treatment days
- Mini-Mental State Examination (MMSE) score of ≥24
- able to provide informed consent
Exclusion Criteria:
- Any condition rendering patient medically unfit for ECT; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in Phase I (routine care)
- Active suicidal intention
- Dementia, intellectual disability, or MMSE <24
- Lifetime history of bipolar affective disorder
- Current history of post-traumatic stress disorder
- Other Axis I diagnosis (DSM-IV)
- ECT in the six months prior to recruitment
- Alcohol dependence or substance misuse in the six months prior to recruitment
- Pregnancy or breast-feeding
- Residing in a nursing home
- Prisoner
- Diagnosis of terminal illness
- Inability or refusal to provide valid informed consent
Sites / Locations
- St Patrick's University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ketamine
Midazolam
Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate >110/minute or systolic/diastolic blood pressure (BP) >180/100 or >20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy.
Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered.