Obsessive-Compulsive Disorder Clinical Trial
Official title:
A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder
This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for
individuals who have not responded or only partially responded to an adequate trial of SRI.
Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials,
response rates have been as low as 40%. Augmentation strategies would be beneficial to
maximize treatment response in OCD.
Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of
action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as
well as inhibit glutamate release. These two neurotransmitters systems have been implicated
in the neurobiology of OCD.
The study will consist of patients who have not attained full response to an SRI. The
patients will be randomized in a double-blind fashion to augmentation with pregabalin
(Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and
increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side
effects. Patients' response to treatment will be measured by the Yale-Brown
Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS),
and the Clinical Global Impression Scale(CGI).
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