Ketamine for Depression Relapse Prevention Following ECT

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02414932
• Date of registration: 08/04/2015
• Prospective Registration: No
• Primary sponsor: St Patrick's Hospital, Ireland
• Public title: Ketamine for Depression Relapse Prevention Following ECT KEEP-WELL
• Scientific title: Ketamine for Depression Relapse Prevention Following ECT: a Randomised Pilot Trial With Blood Biomarker Evaluation
• Date of first enrolment: April 2015
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02414932
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

Ireland

Contacts

• Name: Declan M McLoughlin
• Affiliation: St Patrick's Hospital/Trinity College

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Midazolam

Drug: Ketamine

Primary Outcome(s)

Completion Rate for Randomised Treatment [Time Frame: 30 months]

Secondary Outcome(s)

Depression Relapse Rate [Time Frame: 6 months]

Secondary ID(s)

SPUH 05/14

2014-004262-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Health Research Board, Ireland

Results

• Results available: Yes
• Date Posted: 06/05/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02414932