Abstract | BACKGROUND: 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.
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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. 25
Issue 4
Pg. E7-22
(Nov 2013)
ISSN: 1547-3325 [Electronic] United States |
PMID | 24199224
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antipsychotic Agents
- Delayed-Action Preparations
- Dibenzothiazepines
- Neurotransmitter Uptake Inhibitors
- Serotonin Uptake Inhibitors
- Quetiapine Fumarate
- Norepinephrine
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Topics |
- Adult
- Antipsychotic Agents
(administration & dosage, adverse effects, pharmacology)
- Anxiety Disorders
(drug therapy)
- Delayed-Action Preparations
(administration & dosage, adverse effects, pharmacology)
- Dibenzothiazepines
(administration & dosage, adverse effects, pharmacology)
- Double-Blind Method
- Drug Administration Schedule
- Drug Synergism
- Drug Therapy, Combination
- Female
- Humans
- Male
- Middle Aged
- Neurotransmitter Uptake Inhibitors
(administration & dosage, pharmacology)
- Norepinephrine
(antagonists & inhibitors)
- Psychiatric Status Rating Scales
- Quetiapine Fumarate
- Selective Serotonin Reuptake Inhibitors
(administration & dosage, pharmacology)
- Treatment Outcome
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