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Psych Congress  

Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone

Authors  
Ken Kramer, PhD
Arif Khan, MD
Suresh Durgam, MD
Changzheng Chen, PhD
Adam Ruth, PhD
Maju Mathews, MD
Carl Gonmoll, MS
Sponsor  
Forest Laboratories, LLC, an affiliate of Actavis, Inc.

Introduction: Generalized anxiety disorder (GAD) is characterized by diverse psychic and somatic symptoms. Vilazodone is an SSRI and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults. Vilazodone was evaluated in 3 positive double-blind, placebo-controlled trials in GAD; post hoc pooled analyses evaluated vilazodone's efficacy across GAD symptom domains. Methods: One fixed-dose (NCT01629966) and 2 flexible-dose studies (NCT01766401, NCT01844115) were pooled; 20-mg/d and 40-mg/d vilazodone doses were combined for analyses. Mean change from baseline to Week 8 in Hamilton Anxiety Rating Scale (HAMA) total score, Psychic and Somatic Anxiety Subscale and individual item scores were evaluated in the intent-to-treat (ITT) population using a mixed-effects model for repeated measures; effect sizes (ES) were estimated. Results: The pooled ITT population comprised 618 placebo patients and 844 vilazodone patients. Vilazodone- versus placebo-treated patients had significantly greater improvements in HAMA total score (LSMD=-1.83; P<.0001; ES=0.26), and Psychic (LSMD=-1.21; P<.0001; ES=0.28) and Somatic Anxiety Subscale (LSMD=-0.63; P=.0012; ES=0.19) scores. Significantly greater improvements for vilazodone versus placebo were seen on all HAMA psychic anxiety items (P value range: <.0001 to <.0280; ES range: 0.13 to 0.32) except insomnia and on all somatic anxiety items (P value range: .0005 to .0134; ES range: 0.15 to 0.20) except gastrointestinal and genitourinary symptoms. Conclusions: Vilazodone- versus placebo-treated patients had significantly greater improvement in HAMA total score, Psychic and Somatic Anxiety Subscale scores, and on 11 of 14 HAMA items. Vilazodone may have broad efficacy across a range of psychic and somatic symptoms in GAD.

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