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
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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“Three RCTs, all in care homes, evaluated music therapy by trained therapists using a specific protocol - typically involving warming up with a well-known song, listening to and then joining in with the music. 28-30”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [28]
In the citing paper
“The largest study, which included participants irrespective of agitation level, found music therapy twice a week for 6 weeks was effective compared with the usual care group. 28”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [28]
Citations
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Statistical power analysis for the behavioral sciences
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Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease
Schneider, L. S., Tariot, P. N., Dagerman, K. S., Davis, S. M., Hsiao, J. K., Ismail, M. S., Lebowitz, B. D., Lyketsos, C. G., Ryan, J. M., Stroup, T. S., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa061240 · Cited by 1,206
Self-citationAtypical antipsychotic drugs and the risk of sudden cardiac death
Ray, W. A., Chung, C. P., Murray, K. T., Hall, K., & Stein, C. M. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0806994 · Cited by 1,194
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Antipsychotic Drug Use and Mortality in Older Adults with Dementia
Gill, S. S., Bronskill, S. E., Normand, S.-L. T., Anderson, G. M., Sykora, K., Lam, K., Bell, C. M., Lee, P. E., Fischer, H. D., Herrmann, N., et al. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-146-11-200706050-00006 · Cited by 624
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Katzman, M. A., Bleau, P., Blier, P., Chokka, P., Kjernisted, K., Van Ameringen, M., & the Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/Association Canadienne des troubles anxieux and McGill University (2014) · BMC Psychiatry · doi:10.1186/1471-244x-14-s1-s1 · Cited by 1,090
“The guidelines include panic disorder, agoraphobia, specific phobia, social anxiety disorder (SAD), generalized anxiety disorder (GAD), as well as obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD).”
BackgroundInfluentialMaust, D. T., Kim, H. M., Seyfried, L. S., Chiang, C., Kavanagh, J., Schneider, L. S., & Kales, H. C. (2015) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2014.3018 · Cited by 617
Abraha, I., Rimland, J. M., Trotta, F. M., Dell'Aquila, G., Cruz-Jentoft, A., Petrovic, M., Gudmundsson, A., Soiza, R., O'Mahony, D., Guaita, A., et al. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-012759 · Cited by 557
“However, their adverse effects are common and problematic, in particular the increased risk of falls and fractures,(24) stroke and even mortality.(25) In addition, there is some evidence that the use of benzodiazepines to treat agitation in patients with dementia may increase cognitive decline(24) and may expose patie…”
BackgroundSolmi, M., Murru, A., Pacchiarotti, I., Undurraga, J., Veronese, N., Fornaro, M., Stubbs, B., Monaco, F., Vieta, E., Seeman, M., et al. (2017) · Therapeutics and Clinical Risk Management · doi:10.2147/tcrm.s117321 · Cited by 438
“19,20 In addition, systematic evidence and meta-analysis indicate that SGAs are frequently used for several off-label indications; 21,22 they have been advocated as “multidimensional” agents.”
Update on Typical and Atypical Antipsychotic Drugs
Meltzer, H. Y. (2012) · Annual Review of Medicine · doi:10.1146/annurev-med-050911-161504 · Cited by 443
“Antipsychotic drugs (APDs) ameliorate hallucinations and delusions in patients with neuropsychiatric disorders, particularly schizophrenia and bipolar disorder, but they vary in efficacy and side effects, as well as mechanism of action (1, 2).”
Background
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)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2011-09-28
- Volume
- 306
- Issue
- 12
- Pages
- 1359
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- 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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