IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
Terminated
Rutgers, The State University of New Jersey
Phase 4
2010-07-01
Post-procedure myalgia (muscle ache) is a well-known and common complication of
Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in
approximately 50% of these cases. The pain is usually described as muscle soreness, similar
to that resulting from strenuous exercise. The myalgias typically begin shortly after the
procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of
patients considered prevention significant and would be willing to pay a median of $33 out of
pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a
further financial burden if these patients are unable to return to work or resume previous
daily activities in the days following the procedure. An agent that could treat and possibly
even prevent these myalgias has the potential to be very beneficial to these patients. IV
ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and
Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an
adjunct to opioid analgesics, and for the reduction of fever.
A Pilot Study of Creatine Monohydrate as an Augmenting Agent for ECT in Persons With Major Depressive Disorder
Recruiting
University of Utah
Phase 3
2020-08-03
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.
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