Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder

Abstract

The objective of this study was to evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) as maintenance monotherapy for patients with generalized anxiety disorder (GAD). Time-to-event (anxiety symptom recurrence; maximum 52 weeks) multicenter, randomized-withdrawal, parallel-group, double-blind, placebo-controlled study of quetiapine XR (50-300 mg/day) following open-label run-in (4-8 weeks) and open-label stabilization (≥ 12 weeks). Primary variable: time from randomization to anxiety event. Secondary variables included: Hamilton Anxiety Rating Scale (HAM-A) total, HAM-A psychic/somatic anxiety factors, Clinical Global Impression-Severity of Illness (CGI-S), and Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scores; adverse events (AE) reporting. Four hundred and thirty-two patients, stabilized on quetiapine XR, were randomized to continue quetiapine XR (N=216) or switch to placebo (N=216). Risk of anxiety symptom recurrence was significantly reduced by 81% for quetiapine XR versus placebo: hazard ratio=0.19 (95% confidence interval 0.12-0.31; P<0.001). Fewer patients receiving quetiapine XR (N=22, 10.2%) than placebo (N=84, 38.9%) experienced anxiety symptom recurrence. Significant differences were observed between quetiapine XR and placebo in: HAM-A total, psychic/somatic, CGI-S (all P<0.001) and Q-LES-Q (P<0.05) scores. AEs (>10%) during open-label treatment were dry mouth, sedation, somnolence, dizziness, fatigue, and constipation. During randomized treatment, the most common AEs for quetiapine XR were headache and nasopharyngitis. Quetiapine XR monotherapy reduced the risk of anxiety symptom recurrence in patients with GAD stabilized on quetiapine XR, with tolerability results consistent with the known profile of quetiapine.

Dispensed prescriptions for quetiapine and other second-generation antipsychotics in Canada from 2005 to 2012: a descriptive study

“…23 The extent of quetiapine use to treat anxiety is unprecedented for an antipsychotic. Although several small randomized trials 24,25 were completed and published earlier, the first large randomized controlled trial (RCT) of quetiapine for anxiety was published in a peer-reviewed journal in 2010 26 followed by 4 others [27][28][29][30] in the following years. A systematic review 31 of RCTs of quetiapine for anxiety found it to be clinically efficacious for generalized anxiety; however, its overall tolerability was poor.…”

Anxiety Disorder Comorbidity in Bipolar Disorder, Schizophrenia and Schizoaffective Disorder

“…The issue of anxiety comorbidity may have implications for treatment choice as well. For example, antipsychotic medications such as quetiapine, which have some evidence for efficacy in anxiety disorders, may be considered [55]. Anxiety symptoms occurring in the context of a primary psychotic or mood disorder may be initially dismissed as psychotic or mood symptoms or be missed altogether.…”

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

“…The findings of randomised placebo-controlled relapseprevention studies in patients who have responded to previous 'open' acute treatment of varying lengths reveal a significant advantage for staying on active medication (agomelatine, duloxetine, escitalopram, paroxetine, pregabalin, quetiapine, venlafaxine, vortioxetine), when compared with switching to placebo, for periods of between 6-18 months (Baldwin et al, 2011bKatzman et al, 2011;Rickels et al, 2010). …”