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Proposal 1373

Title of the Proposed Research

An exploratory analysis of headache in placebo controlled trials of paroxetine for generalized anxiety disorder

Lead Researcher

Jonathan H. Smith, M.D.

Affiliation

University of Kentucky

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

23 March 2016

Lay Summary

Headache is highly prevalent and among the leading causes of neurological disability worldwide. Headache disorders are associated with psychiatric co-morbidity, including generalized anxiety and panic disorders. These latter disorders are most often treated with selective serotonin receptor inhibitors, such as paroxetine. However, paroxetine has been associated with headache as an adverse reaction in 6 to 18% of those treated in clinical trial settings. In the evaluation of an individual presenting with headache, it would be clinically relevant to recognize the subset of individuals who are at greatest risk for headache attributable to an adverse reaction of paroxetine. This would allow the clinician to consider discontinuation of paroxetine in individuals reporting headache where the association is thought to be the strongest, and avoid inappropriate discontinuation of paroxetine in individuals when the association is less likely.

To address this issue, we will perform logistic regression analysis of pooled phase 3 clinical trial data of paroxetine in generalized anxiety disorder. The results will be communicated to headache specialists through abstract and journal submissions.

Study Data Provided

Study GSK-PAR 29060 637: A double-blind, placebo controlled study to evaluate the efficacy and tolerability of paroxetine in patients with Generalised Anxiety Disorder (GAD)
Study GSK-BRL-029060/RSD-101336/1/CPMS-641: A Randomized, Double-Blind, Placebo Controlled, Fixed Dosage Trial to Evaluate the Efficacy and Tolerability of 20 and 40mg/day Paroxetine in Patients with Generalized Anxiety Disorder
Study GSK-PAR 29060/642: A Randomized, Double-Blind, Placebo Controlled, Flexible Dosage Trial to Evaluate the Efficacy and Tolerability of Paroxetine in Patients with Generalized Anxiety Disorder
Study GSK-29060/791: A Randomized, Double-Blind, Placebo-Controlled, Flexible Dosage Trial to Evaluate the Efficacy and Tolerability of Paroxetine CR in Patients with Generalized Anxiety Disorder (GAD)

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.