Ketamine for Depression Relapse Prevention Following ECT (KEEP-WELL)
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|ClinicalTrials.gov Identifier: NCT02414932|
Recruitment Status : Completed
First Posted : April 13, 2015
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Ketamine Drug: Midazolam||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ketamine for Depression Relapse Prevention Following ECT: a Randomised Pilot Trial With Blood Biomarker Evaluation|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||April 7, 2017|
|Actual Study Completion Date :||April 7, 2017|
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.
Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
Other Name: Ketalar
Active Comparator: Midazolam
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.
Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
Other Name: Hypnovel
- Recruitment rate [ Time Frame: 30 months ]Process outcomes are primary in this pilot trial. These include recruitment methods and rate and will be assessed following the completion of the trial
- Depression relapse rate [ Time Frame: 6 months ]Clinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) will be used to assess for the main clinical outcome, the relapse rate over six months. Criteria for relapse are ≥10 point increase in HRSD-24 compared to baseline Phase 2 score plus HRSD ≥16; in addition, increase in the HRSD should be maintained one week later (if indicated, additional follow-ups will be arranged). Hospital admission, further ECT, and deliberate self-harm/suicide also constitute relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414932
|St Patrick's University Hospital|
|Dublin, Ireland, 8|
|Principal Investigator:||Declan M McLoughlin||St Patrick's Hospital/Trinity College|