Quetiapine Monotherapy as Treatment for Anxiety Symptoms in Patients With Bipolar Depression: A Pooled Analysis of Results From 2 Double-Blind, Randomized, Placebo-Controlled Studies
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OBJECTIVE: To evaluate the efficacy and tolerability of quetiapine monotherapy for anxiety symptoms in patients with bipolar disorder experiencing depression in the BipOLar DEpRession (BOLDER I and II) studies. METHOD: A post hoc analysis of anxiety symptoms in 1,051 acutely depressed patients with bipolar I or II disorder (DSM-IV) from 2 double-blind, randomized, placebo-controlled 8-week studies of quetiapine (300 or 600 mg once daily) was conducted. Anxiety symptoms were assessed using Hamilton Anxiety Rating Scale (HARS) total and psychic (items 1-6, 14) and somatic (items 7-13) anxiety subscale scores (mixed-model repeated measure and last-observation-carried-forward analysis of change from baseline at each assessment). The BOLDER I study was conducted between September 2002 and October 2003, and the BOLDER II study was conducted between June 2004 and August 2005. RESULTS: Mean baseline HARS total scores were similar across the treatment groups (300 mg/d: 18.9, 600 mg/d and placebo: both 18.6). There was a significantly greater improvement from baseline in mean HARS total scores at the first evaluation (week 1) in both quetiapine groups compared with placebo (300 mg/d: -4.6, P < .001 and 600 mg/d: -4.1, P = .003 vs placebo: -2.8). These improvements were sustained through week 8 with both quetiapine doses (300 mg/d: -10.1, P < .001 and 600 mg/d: -10.5, P < .001 vs placebo: -6.9). At week 8, there was also significant improvement from baseline in HARS psychic and somatic anxiety subscale scores compared with placebo (P < .001). The baseline severity of anxiety did not impact the improvement in depressive symptoms. Common adverse events included dry mouth, sedation, somnolence, and dizziness. CONCLUSIONS: In this pooled analysis, quetiapine monotherapy was more effective than placebo and generally well tolerated for the treatment of both depressive and anxiety symptoms in patients with bipolar disorder. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00060489 (BOLDER I) and NCT00083954 (BOLDER II).
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Secondary analyses from several RCTs indicate that quetiapine monotherapy significantly reduces symptoms of generalized anxiety disorder and panic disorder in patients with bipolar depression.
“Further, secondary analyses from several RCTs indicate that quetiapine monotherapy significantly reduces symptoms of GAD and panic disorder in patients with bipolar depression.290, 313, 725”
From Canadian Network for Mood and Anxiety Treatments ( <scp>CANMAT</scp> ) and International Society for Bipolar Disorders ( <scp>ISBD</scp> ) 2018 guidelines for the management of patients with bipolar disorder (2018) · cites this paper as [313]
The Abstract and Discussion report that a secondary analysis of two randomized trials found quetiapine monotherapy reduced anxiety symptoms in patients with bipolar depression. The Discussion explicitly says patients meeting diagnostic criteria for comorbid anxiety disorders were excluded, so these trials do not establish reductions in symptoms of diagnosed GAD or panic disorder. (LLM, conf=0.91)
Experimental — accuracy not yet measuredA pooled analysis of two double-blind RCTs demonstrated that quetiapine is more effective than placebo in relieving symptoms of anxiety co-occurring alongside bipolar depression.
“A pooled analysis of two double‐blind RCTs demonstrated that quetiapine is more effective than placebo in relieving symptoms of anxiety co‐occurring alongside bipolar depression,313 and olanzapine‐fluoxetine combination has also been shown to be effective.314”
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- Authors
- Lydiard, R. B., Culpepper, L., Schiöler, H., Gustafsson, U., & Paulsson, B.
- Affiliations
- Medical University of South Carolina (US)
- Boston University (US)
- Corresponding author
- Culpepper, Larry
- Venue
- The Primary Care Companion to The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2009-10-15
- Volume
- 11
- Issue
- 5
- Pages
- 215-225
- ISSN
- 1523-5998 (ISSN-L)
- 1555-211X
- PMC
- PMC2781033
- OpenAlex
- W2063359938
- Cited by
- 23
- References
- 38
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 2 · 2021: 2 · 2018: 2 · 2016: 2 · 2015: 2 · 2014: 3 · 2013: 1 · 2012: 5
- FWCI
- 1.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Primary Care Companion to The Journal of Clinical Psychiatry (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs
- AstraZeneca
- School of Medicine, Boston University
- University of South Carolina
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- quetiapine, bipolar depression, bipolar disorder, anxiety symptoms, atypical antipsychotics, monotherapy, Hamilton Anxiety Rating Scale, treatment efficacy, tolerability, adverse events, sedation, xerostomia, dizziness, sleepiness, dose comparison, placebo comparison, bipolar I disorder, bipolar II disorder
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