Estimation of symptom-free days in generalized anxiety disorder.
OBJECTIVE
The efficacy of treatments for generalized anxiety disorder has usually been measured in terms of response or remission of symptoms. These endpoints, however, may not adequately capture the transient periods of symptom abatement and relapse characteristic of chronic psychiatric disorders. Here, we evaluate the measurement of treatment effectiveness in terms of the number of symptom-free days (SFDs).


METHODS
A pooled analysis was performed of data from five manufacturer-initiated trials of venlafaxine extended-release (XR) in patients with generalized anxiety disorder without co-morbid major depressive disorder. The trials were randomized, double-blind, placebo-controlled and of 8 weeks duration (total intent-to-treat population 1295 venlafaxine XR, 544 placebo). Two of the studies had extensions up to 6 months (intent-to-treat population 514 venlafaxine XR, 253 placebo). The patients were >or= 18 years of age with a Hamilton Rating Scale for Anxiety (HAM-A) score of >or= 18.


METHODS
SFDs were estimated using weekly scores on the HAM-A. Values of 7 and 0 SFDs, respectively, were assigned to each week the patient had a HAM-A score of <or= 7 (the remission threshold) and >or= 18 (the minimum threshold for anxiety). Fractional SFD values were assigned proportionately to weekly HAM-A scores between 7 and 18.


RESULTS
The median (inter-quartile range) SFDs were 19 (2-36) for venlafaxine XR and 10 (0-27) for placebo in the 8-week studies (p < 0.0001). In the 6-month extension studies the SFDs were 102 (27-139) for venlafaxine XR and 36 (0-94) for placebo (p < 0.0001).


CONCLUSIONS
SFDs differentiate between active treatment and placebo in clinical trials and may be an appropriate measure of treatment effectiveness.
Wyeth Research, Collegeville, USA. Gwan@mccus.jnj.com
George J
GJ
Wan
Huabin F
HF
Zhang
Michael A
MA
Tedeschi
David
D
Hackett
D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy*; D016009:Chi-Square Distribution; D003511:Cyclohexanols / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014481:United States; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride