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Cited by 559Schizophrenia research and treatmentTreatment of Major DepressionPharmaceutical studies and practices

The DOI matches its Crossref record; 80 of the 80 references it cites were found in a registry or an index.

Efficacy and Comparative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults: A Systematic Review and Meta-analysis

Maher, Alicia Ruelaz, Maglione, Margaret, Bagley, Steven, Suttorp, Marika, Hu, Jian-Hui, Ewing, Brett, Wang, Zhen, Timmer, Martha, Sultzer, David, Shekelle, Paul G.·2011·JAMA
DOI 10.1001/jama.2011.1360
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Abstract

CONTEXT: Atypical antipsychotic medications are commonly used for off-label conditions such as agitation in dementia, anxiety, and obsessive-compulsive disorder. OBJECTIVE: To perform a systematic review on the efficacy and safety of atypical antipsychotic medications for use in conditions lacking approval for labeling and marketing by the US Food and Drug Administration. DATA SOURCES AND STUDY SELECTION: Relevant studies published in the English language were identified by searches of 6 databases (PubMed, EMBASE, CINAHL, PsycInfo, Cochrane DARE, and CENTRAL) from inception through May 2011. Controlled trials comparing an atypical antipsychotic medication (risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, or paliperidone) with placebo, another atypical antipsychotic medication, or other pharmacotherapy for adult off-label conditions were included. Observational studies with sample sizes of greater than 1000 patients were included to assess adverse events. DATA EXTRACTION: Independent article review and study quality assessment by 2 investigators. DATA SYNTHESIS: Of 12 228 citations identified, 162 contributed data to the efficacy review. Among 14 placebo-controlled trials of elderly patients with dementia reporting a total global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effects sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, a pooled analysis of 3 trials showed that quetiapine was associated with a 26% greater likelihood of a favorable response (defined as at least 50% improvement on the Hamilton Anxiety Scale) compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of a favorable response (defined as a 25% improvement on the Yale-Brown Obsessive Compulsive Scale) compared with placebo. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH] = 87), stroke (NNH = 53 for risperidone), extrapyramidal symptoms (NNH = 10 for olanzapine; NNH = 20 for risperidone), and urinary tract symptoms (NNH range = 16-36). In nonelderly adults, adverse events included weight gain (particularly with olanzapine), fatigue, sedation, akathisia (for aripiprazole), and extrapyramidal symptoms. CONCLUSIONS: Benefits and harms vary among atypical antipsychotic medications for off-label use. For global behavioral symptom scores associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder; however, adverse events were common.

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Metadata

Authors
Maher, A. R., Maglione, M., Bagley, S., Suttorp, M., Hu, J.-H., Ewing, B., Wang, Z., Timmer, M., Sultzer, D., & Shekelle, P. G.
Affiliations
  • RAND Corporation (US)
  • United States Department of Veterans Affairs (US)
  • University of California, Los Angeles (US)
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2011-09-28
Volume
306
Issue
12
Pages
1359
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2011.1360
OpenAlex
W2072303299
Cited by
558
References
80
Citations by year
2026: 7 · 2025: 19 · 2024: 22 · 2023: 24 · 2022: 63 · 2021: 39 · 2020: 31 · 2019: 29 · 2018: 33 · 2017: 35 · 2016: 52 · 2015: 50 · 2014: 55 · 2013: 52 · 2012: 45
FWCI
33.70
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Funders
U.S. Public Health Service (HHSA2902007100621)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
atypical antipsychotics, off-label drug use, generalized anxiety disorder, obsessive-compulsive disorder, risperidone, olanzapine, quetiapine, aripiprazole, extrapyramidal symptoms, stroke risk, adverse drug reactions, comparative effectiveness, elderly patients, treatment efficacy and safety, number needed to harm
MeSH terms
Adult, Aged, Anxiety Disorders, Dementia, Humans, Middle Aged, Obsessive-Compulsive Disorder, Antipsychotic Agents, United States, United States Food and Drug Administration, Treatment Outcome, Off-Label Use

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