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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]
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Rashid, N., Wetmore, J. B., Irfan, M., & Abler, V. (2022) · American Journal of Alzheimer s Disease & Other Dementias® · doi:10.1177/15333175221081374 · Cited by 4
Patterns and predictors of oral antipsychotic prescribing in adult patients with schizophrenia
Vadiei, N., El-Ali, J., Delaune, J., Wild, C., & Liu, Y. (2022) · Exploratory Research in Clinical and Social Pharmacy · doi:10.1016/j.rcsop.2022.100148 · Cited by 4
Risk of Breast Cancer in Association with the Use of Second-generation Antipsychotics
Joo, S. W., Lee, B. C., Lee, J. S., & Seo, G. H. (2022) · Clinical Psychopharmacology and Neuroscience · doi:10.9758/cpn.2022.20.4.675 · Cited by 4
“Antipsychotic drugs have been used for the treatment of several psychiatric disorders, including schizophrenia spectrum disorder, dementia, obsessive-compulsive disorder, and generalized anxiety disorder [1].”
BackgroundShamshoum, H., Medak, K. D., McKie, G. L., Jeromson, S., Hahn, M., & Wright, D. C. (2023) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2023.115671 · Cited by 4
Chao, X.-L., Jiang, S., Xiong, J., Zhan, J., Wei, B., Chen, C., & Yang, Y. (2020) · Current Medical Science · doi:10.1007/s11596-020-2214-0 · Cited by 4
Lohse, M. J., & Müller-Oerlinghausen, B. (2018) · Springer eBooks · doi:10.1007/978-3-662-57386-0_41 · Cited by 4
Gallagher, S. P., & Bouchard, L. (2023) · Journal of the American Association of Nurse Practitioners · doi:10.1097/jxx.0000000000000899 · Cited by 4
Major Neurocognitive Disorders (Dementias)
Sher, Y. I., & Maldonado, J. R. (2014) · Springer eBooks · doi:10.1007/978-3-319-11005-9_13 · Cited by 4
Benzodiazepines for generalised anxiety disorder (GAD)
Gale, C. K., Herbison, P., Glue, P., Coverdale, J., & Guaiana, G. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001846.pub3 · Cited by 4
RetractedAntidepressants versus placebo for generalised anxiety disorder (GAD)
Guaiana, G., Barbui, C., & Abouhassan, R. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012942 · Cited by 4
Arnold, P. D., & Kronenberg, S. (2017) · Wiley eBooks · doi:10.1002/9781118890233.ch60 · Cited by 4
Zheng, L., Xiong, Y., Nie, W., & Si, T. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.120462 · Cited by 3
Antipsychotic Misuse: A Silent but Growing Public Health Hazard
Bhardwaj, S., Pathak, K., McLenon, M., Spector, S., & Tu, K. (2025) · Cureus · doi:10.7759/cureus.98275 · Cited by 3
“Despite their widespread use for insomnia, anxiety, personality disorders, dementia-related behaviors, and post-traumatic stress disorder, controlled trials generally show minimal or no benefit [3].”
Medak, K. D., Jeromson, S., Bellucci, A., Arbeau, M., & Wright, D. C. (2023) · iScience · doi:10.1016/j.isci.2023.108628 · Cited by 3
Ray, N. R., Kumar, A., Zaman, A. F., del Rosario, P., Mena, P. R., Manoochehri, M., Stein, C. M., Vito, A. N. D., Sweet, R. A., Hohman, T. J., et al. (2024) · Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring · doi:10.1002/dad2.70000 · Cited by 3
Synthesis, Experimental and Computational Evaluation of SERAAK1 as a 5-HT2A Receptor Ligand
Zięba, A., Kędzierska, E., Jastrzębski, M. K., Karcz, T. P., Olejarz‐Maciej, A., Sumara, A., Laitinen, T., Wróbel, T. M., Fornal, E., Castro, M., et al. (2025) · Molecules · doi:10.3390/molecules30102165 · Cited by 3
“Despite the availability of medications targeting the serotonin systems, many of the available treatments are associated with the development of severe side effects or report limited efficacy [20].”
Safety and Tolerability of Antipsychotics
Jann, M. W., & Kennedy, W. K. (2015) · Springer eBooks · doi:10.1007/978-3-319-24741-0_9 · Cited by 3
Carnahan, R. M., Daly, J. M., Minion, S. C., Gryzlak, B. M., Weckmann, M. T., Levy, B. T., & Bay, C. P. (2019) · Journal of Primary Care & Community Health · doi:10.1177/2150132719840113 · Cited by 3
Recent developments in geriatric psychopharmacology
Aftab, A., Lam, J. A., Liu, F., Ghosh, A., & Sajatovic, M. (2021) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2021.1882848 · Cited by 3
Lohse, M. J., & Müller-Oerlinghausen, B. (2015) · Springer eBooks · doi:10.1007/978-3-662-47186-9_38 · Cited by 3
Deciphering Risperidone-Induced Lipogenesis by Network Pharmacology and Molecular Validation
Fu, Y., Yang, K., Huang, Y., Zhang, Y., Li, S., & Li, W.-D. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2022.870742 · Cited by 2
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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