A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder
Status:
Recruiting
Trial end date:
2023-08-02
Target enrollment:
Participant gender:
Summary
We propose to determine if augmentation of electroconvulsive therapy (ECT) utilized for the
treatment of major depressive disorder (MDD) with daily oral creatine will lead to an
accelerated response to treatment, an overall increase in response rate, and will protect
against cognitive adverse effects associated with ECT. We propose to conduct a two-arm,
parallel, randomized, double-blinded, placebo-controlled trial, with a treatment group
receiving 20 g oral loading dose of creatine for 1 week starting the day before initiating
ECT, followed by 5 g oral creatine daily for roughly five weeks, including the approximately
three-week ECT treatment course and a two-week follow-up period. Response to treatment will
be assessed using the Quick Inventory of Depressive Symptomatology (QIDS) at each treatment
and the 17-item Hamilton Depression Rating Scale (HAM-D17) at the end of each week.