Study Evaluating Venlafaxine ER in Adults With Panic Disorder

Phase 3 Completed 343 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

Treatment

Summary

The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.

Timeline

Start: 2001-04
Primary completion: 2002-12
Completion: 2002-12

Outcome

Missed primary endpoint

paper At week 10, the percentage of patients who were free from full-symptom panic attacks was 52% in the venlafaxine ER group and 43% in the placebo group (p = .11). PMID 19358784 ↗

paper although the results fell just short of significance on the primary outcome measure. PMID 19358784 ↗

Publications

Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. doi: 10.4088/jcp.08m04238. Epub 2009 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venlafaxine	Small molecule	75 mg	—
Subject	Venlafaxine	Small molecule	225 mg	—