Abstract Details

Title Maraviroc pharmacotherapy in post-stroke depression: A proof of concept clinical trial

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) S20 - Cerebrovascular Disease and Interventional Neurology: Clinical Trials and Outcomes Studies (4:06 PM-4:18 PM)

Poster/Presentation
Number 004

Background Depression and anxiety affect up to 60% of stroke survivors; they play a critical role in shaping long-term stroke outcome. Currently effective therapeutic options are relatively few.
Recent studies by our group and colleagues showed that the FDA-approved HIV-drug, maraviroc, a CCR5-antagonist, improved cognitive function in a rodent stroke model. Maraviroc modulates several signaling cascades implicated in learning, memory and depression. We have recently reported that in a large clinical stroke patients cohort, carriers of a natural-occurring mutation that blocks CCR5, had reduced depressive symptoms, anxiety and cognitive deficits two-years post-stroke. Based on that we conducted the first open pilot-trial using Maraviroc as augmentation treatment in PSD patients who failed to achieve remission after adequate psychopharmacologic treatment.

Objective To evaluate the tolerability, potential efficacy, and time to potential efficacy
Of Maraviroc for post-stroke depression(PSD).

Design/Methods A 10-week, open-label, proof-of-concept trial of daily-oral 300mg Maraviroc was conducted in treating recent subcortical stroke patients suffering from PSD. Subjects were followed for another 8-weeks after completing treatment. Response rate defined as a reduction in Montgomery-Asberg-Depression-Rating Scale(MADRS) from baseline to week-10 of >30%, and remission rate as MADRS score at week-10 of <10. Subjects completed the quick-inventory of depressive symptoms-self report(QIDS-SR16) score.

Results MADRS score was reduced from baseline to week-10(mean change:−16.4±9.3,p <0.001), as was the QIDS-SR16 score(mean change:−6.5±6.4,p=0.01).
At the end of 10-weeks Maraviroc augmentation, 70%(7/10) of the patients achieved response and 40%(4/10) achieved remission, with shorter time-to-response than current antidepressants in use. Some of the responders(4/7) experienced worsening of their depressive symptoms after stopping the study drug(6/7). Maraviroc was well tolerated with no reported adverse events or discontinuation due to intolerance.

Conclusions Our proof-of-concept study suggests that Maraviroc 300mg/day may be an effective and well-tolerated pharmacological treatment option for PSD.
Larger placebo-controlled studies are needed to evaluate the effects of Maraviroc augmentation in post-stroke depressive patients.

Authors/Disclosures
Einor Ben Assayag, PhD (Tel Aviv Sourasky Medical Center) PRESENTER	The institution of Dr. Ben Assayag has received research support from Alzheimer's Association. Dr. Ben Assayag has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
	No disclosure on file
Estelle Seyman	Estelle Seyman has nothing to disclose.
Ofer Rotschild	No disclosure on file
Hen Hallevi, MD (Dept of Neurology)	No disclosure on file