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Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial.
Int Clin Psychopharmacol. 2011 Jan; 26(1):11-24.IC

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.

Authors+Show Affiliations

START Clinic for Mood and Anxiety Disorders, Toronto, Ontario, Canada. mkatzman@startclinic.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20881846

Citation

Katzman, Martin A., et al. "Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy as Maintenance Treatment for Generalized Anxiety Disorder: a Long-term, Randomized, Placebo-controlled Trial." International Clinical Psychopharmacology, vol. 26, no. 1, 2011, pp. 11-24.
Katzman MA, Brawman-Mintzer O, Reyes EB, et al. Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2011;26(1):11-24.
Katzman, M. A., Brawman-Mintzer, O., Reyes, E. B., Olausson, B., Liu, S., & Eriksson, H. (2011). Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial. International Clinical Psychopharmacology, 26(1), 11-24. https://doi.org/10.1097/YIC.0b013e32833e34d9
Katzman MA, et al. Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy as Maintenance Treatment for Generalized Anxiety Disorder: a Long-term, Randomized, Placebo-controlled Trial. Int Clin Psychopharmacol. 2011;26(1):11-24. PubMed PMID: 20881846.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial. AU - Katzman,Martin A, AU - Brawman-Mintzer,Olga, AU - Reyes,Efren B, AU - Olausson,Bengt, AU - Liu,Sherry, AU - Eriksson,Hans, PY - 2010/10/1/entrez PY - 2010/10/1/pubmed PY - 2011/3/19/medline SP - 11 EP - 24 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 26 IS - 1 N2 - 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. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/20881846/Extended_release_quetiapine_fumarate__quetiapine_XR__monotherapy_as_maintenance_treatment_for_generalized_anxiety_disorder:_a_long_term_randomized_placebo_controlled_trial_ L2 - https://doi.org/10.1097/YIC.0b013e32833e34d9 DB - PRIME DP - Unbound Medicine ER -