Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study.

Abstract

BACKGROUND:

For many patients with generalized anxiety disorder (GAD), first-line treatment does not lead to remission. This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate (quetiapine XR) in patients with GAD and an inadequate response to selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

METHODS:

Patients were randomized to quetiapine XR or placebo adjunctive to SSRI/SNRIs in an 11-week study. The primary endpoint was change from randomization to week 8 in Hamilton Anxiety Rating Scale (HAM-A) total score. Secondary variables were HAM-A psychic/somatic clusters, response, and remission, and Clinical Global Impression–Severity of Illness (CGI-S) score.

RESULTS:

A total of 409 patients received quetiapine XR (n=209) or placebo (n=200). The week 8 mean change in HAM-A total score was not statistically significant for quetiapine XR (–10.74; P=.079) vs placebo (–9.61). Secondary variables were generally consistent with the primary analysis, except for a significant reduction in HAM-A total score (week 1) and significant improvements in HAM-A psychic cluster and CGI-S total scores (week 8). Adverse events included dry mouth, somnolence, sedation, headache, and dizziness.

CONCLUSIONS:

In patients with GAD and an inadequate response to SSRI/SNRIs, adjunctive quetiapine XR did not show a statistically significant effect for the primary endpoint at week 8, although some secondary endpoints were statistically significant vs placebo. Quetiapine XR was generally well tolerated.

• Authors: Arifulla Khan, Sarah Atkinson, Irina Mezhebovsky, Fahua She, Todd Leathers, Sanjeev Pathak
• Journal: Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists (Ann Clin Psychiatry) Vol. 26 Issue 1 Pg. 3-18 (Feb 2014) ISSN: 1547-3325 [Electronic] United States
• PMID: 24660224 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Delayed-Action Preparations
• Dibenzothiazepines
• Neurotransmitter Uptake Inhibitors
• Serotonin Uptake Inhibitors
• Quetiapine Fumarate

Topics

• Adult
• Antipsychotic Agents (administration & dosage, adverse effects, pharmacology)
• Anxiety Disorders (drug therapy)
• Delayed-Action Preparations
• Dibenzothiazepines (administration & dosage, adverse effects, pharmacology)
• Double-Blind Method
• Drug Synergism
• Drug Therapy, Combination
• Female
• Humans
• Male
• Middle Aged
• Neurotransmitter Uptake Inhibitors (administration & dosage, pharmacology)
• Psychiatric Status Rating Scales
• Quetiapine Fumarate
• Selective Serotonin Reuptake Inhibitors (administration & dosage, pharmacology)
• Severity of Illness Index
• Treatment Outcome