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.
“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]
The largest music therapy 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.
“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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Update on Typical and Atypical Antipsychotic Drugs
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“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).”
BackgroundLivingston, G., Kelly, L., Lewis-Holmes, E., Baio, G., Morris, S., Patel, N., Omar, R. Z., Katona, C., & Cooper, C. (2014) · British Journal of Psychiatry · doi:10.1192/bjp.bp.113.141119 · Cited by 426 · see citing works
Review of Safety and Efficacy of Sleep Medicines in Older Adults
Schroeck, J. L., Ford, J., Conway, E. L., Kurtzhalts, K. E., Gee, M. E., Vollmer, K. A., & Mergenhagen, K. A. (2016) · Clinical Therapeutics · doi:10.1016/j.clinthera.2016.09.010 · Cited by 374 · see citing works
Ten common questions (and their answers) about off-label drug use
Wittich, C. M., Burkle, C. M., & Lanier, W. L. (2012) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2012.04.017 · Cited by 368 · see citing works
Olfson, M., Blanco, C., Liu, S.-M., Wang, S., & Correll, C. U. (2012) · Archives of General Psychiatry · doi:10.1001/archgenpsychiatry.2012.647 · Cited by 351 · see citing works
“The metabolic safety concerns of antipsychotic medications(16,17) focus our attention on antipsychotic prescribing practices in the community, especially on the extent to which antipsychotics are used to treat disorders for which there is limited empirical evidence of efficacy.(15,18) Young people may be especially se…”
BackgroundPharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options
Garakani, A., Murrough, J. W., Freire, R. C., Thom, R. P., Larkin, K., Buono, F. D., & Iosifescu, D. V. (2020) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2020.595584 · Cited by 440 · see citing works
Best practice in the management of behavioural and psychological symptoms of dementia
Tible, O., Riese, F., Savaskan, E., & von Gunten, A. (2017) · Therapeutic Advances in Neurological Disorders · doi:10.1177/1756285617712979 · Cited by 302 · see citing works
Watson, D., Levin‐Aspenson, H. F., Waszczuk, M. A., Conway, C. C., Dalgleish, T., Dretsch, M. N., Eaton, N. R., Forbes, M. K., Forbush, K. T., Hobbs, K. A., et al. (2022) · World Psychiatry · doi:10.1002/wps.20943 · Cited by 285 · see citing works
Huybrechts, K. F., Gerhard, T., Crystal, S., Olfson, M., Avorn, J., Levin, R., Lucas, J. A., & Schneeweiß, S. (2012) · BMJ · doi:10.1136/bmj.e977 · Cited by 264 · see citing works
Antipsychotic use in dementia: a systematic review of benefits and risks from meta-analyses
Tampi, R. R., Tampi, D. J., Balachandran, S., & Srinivasan, S. (2016) · Therapeutic Advances in Chronic Disease · doi:10.1177/2040622316658463 · Cited by 267 · see citing works
“The rest of the 12 meta-analyses included individuals with dementia [Schneider et al. 1990, 2005, 2006; Kirchner et al. 2001; Yury and Fisher, 2007; Cheung and Stapelberg, 2011; Maher et al. 2011; Declercq et al. 2013; Ma et al. 2014; Pan et al. 2014; Tan et al. 2015; Hulshof et al. 2015].”
BackgroundMethodResultInfluentialTreatment of Young People With Antipsychotic Medications in the United States
Olfson, M., King, M. D., & Schoenbaum, M. (2015) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2015.0500 · Cited by 252 · see citing works
Update on weight-gain caused by antipsychotics: a systematic review and meta-analysis
Barton, B. B., Segger, F., Fischer, K., Obermeier, M., & Musil, R. (2020) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2020.1713091 · Cited by 216 · see citing works
Treating comorbid anxiety and depression: psychosocial and pharmacological approaches
Coplan, J. D. (2015) · World Journal of Psychiatry · doi:10.5498/wjp.v5.i4.366 · Cited by 207 · see citing works
Dementia Prevention and Treatment
Reuben, D. B., Kremen, S. A., & Maust, D. T. (2024) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2023.8522 · Cited by 214 · see citing works
The importance of gene–environment interactions in human obesity
Reddon, H., Guéant, J., & Meyre, D. (2016) · Clinical Science · doi:10.1042/cs20160221 · Cited by 201 · see citing works
“Weight gain is a well-known adverse effect of antipsychotic medication (52), but a considerable degree of interindividual variability has been described in literature (53).”
BackgroundYunusa, I. U., Alsumali, A., Garba, A. E., Regestein, Q. R., & Eguale, T. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.0828 · Cited by 203 · see citing works
Relapse Risk after Discontinuation of Risperidone in Alzheimer's Disease
Devanand, D. P., Mintzer, J. E., Schultz, S. K., Andrews, H., Sultzer, D. L., de la Pena, D., Gupta, S., Colon, S., Schimming, C., Pelton, G. H., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1114058 · Cited by 193 · see citing works
“Sedation 20 (11) 7 (10) 5 (12) 1 (8) 1 (4) 1 (8)”
Self-citationBallard, C. G., Bannister, C., Khan, Z., Cummings, J. L., Demos, G., Coate, B., Youakim, J. M., Owen, R., Stankovic, S., Tomkinson, E. B., et al. (2018) · The Lancet Neurology · doi:10.1016/s1474-4422(18)30039-5 · Cited by 192 · see citing works
Psychosis in Alzheimer disease—mechanisms, genetics and therapeutic opportunities
Ismail, Z., Creese, B., Aarsland, D., Kales, H. C., Lyketsos, C. G., Sweet, R. A., & Ballard, C. (2022) · Nature Reviews Neurology · doi:10.1038/s41582-021-00597-3 · Cited by 189 · see citing works
Workgroup, A. C. W. (2013) · Journal of the American Geriatrics Society · doi:10.1111/jgs.12226 · Cited by 191 · see citing works
Weight gain and antipsychotics: a drug safety review
Musil, R., Obermeier, M., Russ, P., & Hamerle, M. (2015) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2015.974549 · Cited by 167 · see citing works
“In a comprehensive review of all off-label used studies, Maglione and Maher found olanzapine to be particularly associated with weight gain across patient populations [84].”
BackgroundCaemmerer, J., Correll, C. U., & Maayan, L. (2012) · Schizophrenia Research · doi:10.1016/j.schres.2012.03.017 · Cited by 182 · see citing works
Late-Life Psychosis: Diagnosis and Treatment
Reinhardt, M. M., & Cohen, C. I. (2015) · Current Psychiatry Reports · doi:10.1007/s11920-014-0542-0 · Cited by 182 · see citing works
Autism Treatment Evaluation Checklist
Rimland, B., & Edelson, S. M. (1999) · PsycTESTS Dataset · doi:10.1037/t03995-000 · Cited by 177 · see citing works
Duloxetine versus other anti-depressive agents for depression
Cipriani, A., Koesters, M., Furukawa, T. A., Nosè, M., Purgato, M., Omori, I. M., Trespidi, C., & Barbui, C. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006533.pub2 · Cited by 167 · see citing works
Summary of the Comparative Effectiveness Review on Off-Label Use of Atypical Antipsychotics
Maher, A. R., & Theodore, G. H. (2012) · Journal of Managed Care Pharmacy · doi:10.18553/jmcp.2012.18.s5-b.1 · Cited by 160 · see citing works
Self-citationDonegan, K. L., Fox, N. C., Black, N. A., Livingston, G., Banerjee, S., & Burns, A. S. (2017) · The Lancet Public Health · doi:10.1016/s2468-2667(17)30031-2 · Cited by 139 · see citing works
“This is because antipsychotic medication is of limited efficacy, 14 associated with an increased mortality and morbidity, 15,16 and often can be successfully withdrawn.”
Mollayeva, T., Kendzerska, T., Mollayeva, S., Shapiro, C. M., Colantonio, A., & Cassidy, J. D. (2014) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2014.10.024 · Cited by 136 · see citing works
Drug, Patient, and Physician Characteristics Associated With Off-label Prescribing in Primary Care
Eguale, T., Buckeridge, D. L., Winslade, N. E., Benedetti, A., Hanley, J. A., & Tamblyn, R. M. (2012) · Archives of Internal Medicine · doi:10.1001/archinternmed.2012.340 · Cited by 129 · see citing works
Hanlon, J. T., Semla, T. P., & Schmader, K. E. (2015) · Journal of the American Geriatrics Society · doi:10.1111/jgs.13807 · Cited by 128 · see citing works
Psychiatric Disorders and Sleep Issues
Sutton, E. L. (2014) · Medical Clinics of North America · doi:10.1016/j.mcna.2014.06.009 · Cited by 119 · see citing works
Behavioral and psychological symptoms in Alzheimer's dementia and vascular dementia
Deardorff, W. J., & Grossberg, G. T. (2019) · Handbook of clinical neurology · doi:10.1016/b978-0-444-64012-3.00002-2 · Cited by 124 · see citing works
Clinically relevant interactions between newer antidepressants and second-generation antipsychotics
Spina, E., & de León, J. (2014) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425255.2014.885504 · Cited by 121 · see citing works
“They are also increasingly used to treat a variety of psychiatric and neurological disorders, including mental and behavioral disorders in dementia, psychosis associated with Parkinson’s disease, treatment-resistant OCD and aggressive behavior [3].”
BackgroundHerrmann, N., Lanctôt, K. L., & Hogan, D. B. (2013) · Alzheimer s Research & Therapy · doi:10.1186/alzrt201 · Cited by 113 · see citing works
Bowring, D. L., Painter, J., & Hastings, R. P. (2019) · Current Developmental Disorders Reports · doi:10.1007/s40474-019-00175-9 · Cited by 114 · see citing works
Kishi, T., Hirota, T., Matsunaga, S., & Iwata, N. (2015) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp-2015-311049 · Cited by 109 · see citing works
Sacarny, A., Barnett, M. L., Le, J., Tetkoski, F., Yokum, D. V., & Agrawal, S. (2018) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2018.1867 · Cited by 110 · see citing works
Rogowska, M., Thornton, M., Creese, B., Velayudhan, L., Aarsland, D., Ballard, C. G., Tsamakis, K., Stewart, R. J., & Mueller, C. (2022) · Drugs & Aging · doi:10.1007/s40266-022-00992-5 · Cited by 110 · see citing works
“Findings on the effectiveness of quetiapine have been variable, with one study reporting a statistically significant improvement in BPRS scores [25], whilst other studies found it ineffective [10, 28, 29].”
BackgroundResultSynthetic cannabinoid withdrawal: a new demand on detoxification services.
Macfarlane, V., & Christie, G. I. G. (2015) · Drug and Alcohol Review · doi:10.1111/dar.12225 · Cited by 112 · see citing works
A European Academy of Neurology guideline on medical management issues in dementia
Frederiksen, K. S., Cooper, C., Frisoni, G. B., Frölich, L., Georges, J., Kramberger, M. G., Nilsson, C., Passmore, P., Ritter, L. M., Religa, D., et al. (2020) · European Journal of Neurology · doi:10.1111/ene.14412 · Cited by 106 · see citing works
Tampi, R. R., & Jeste, D. V. (2022) · American Journal of Psychiatry · doi:10.1176/appi.ajp.20220508 · Cited by 103 · see citing works
Correll, C. U., Joffe, B. I., Rosen, L. M., Sullivan, T. B., & Joffe, R. T. (2015) · World Psychiatry · doi:10.1002/wps.20187 · Cited by 102 · see citing works
“They have proven to be effective for schizophrenia (4,5), but their use has extended to major mood disorders (6,7) and a broad range of other psychiatric illness (8,9).”
BackgroundMatsuda, Y., Kishi, T., Shibayama, H., & Iwata, N. (2013) · Human Psychopharmacology Clinical and Experimental · doi:10.1002/hup.2286 · Cited by 101 · see citing works
“…olanzapine, and risperidone significantly reduced global BPSD scores compared with a placebo, SGAs produced more frequent deadly side effects including cardiovascular events, cerebrovascular accidents, anticholinergic events, sedation, and extrapyramidal symptoms (EPS) (Maher et al., 2011).”
BackgroundAssociation of Antipsychotic Treatment With Risk of Unexpected Death Among Children and Youths
Ray, W. A., Stein, C. M., Murray, K. T., Fuchs, D. C., Patrick, S. W., Daugherty, J. R., Hall, K., & Cooper, W. O. (2018) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2018.3421 · Cited by 101 · see citing works
Atypical antipsychotics for insomnia: a systematic review
Thompson, W., Quay, T. A. W., Rojas‐Fernandez, C. H., Farrell, B. J., & Bjerre, L. M. (2016) · Sleep Medicine · doi:10.1016/j.sleep.2016.04.003 · Cited by 97 · see citing works
Consensus and variations in opinions on delirium care: a survey of European delirium specialists
Morandi, A., Davis, D. H. J., Taylor, J., Bellelli, G., Olofsson, B., Kreisel, S. H., Teodorczuk, A., Kamholz, B. A., Hasemann, W., Young, J. B., et al. (2013) · International Psychogeriatrics · doi:10.1017/s1041610213001415 · Cited by 97 · see citing works
Schoretsanitis, G., Spina, E., Hiemke, C., & de León, J. (2017) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2017.1345623 · Cited by 94 · see citing works
Diagnosis and Management of Behavioral Issues in Frontotemporal Dementia
Manoochehri, M., & Huey, E. (2012) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-012-0302-7 · Cited by 89 · see citing works
“[60] found that atypical antipsychotics, including risperidone, arepiprazole, olanzapine, and quetiapine, all have a small but statistically significant effect in decreasing agitation, psychosis, and overall behavioral disturbances in dementia (mostly AD) patients.”
BackgroundCognitive Therapy for dementia patients: a systematic review
Carrion, C., Folkvord, F., Anastasiadou, D., & Aymerich, M. (2018) · Dementia and Geriatric Cognitive Disorders · doi:10.1159/000490851 · Cited by 91 · see citing works
Workgroup, A. C. W. (2014) · Journal of the American Geriatrics Society · doi:10.1111/jgs.12770 · Cited by 91 · see citing works
Albert, U., Marazziti, D., Di Salvo, G., Solia, F., Rosso, G., & Maina, G. (2019) · Current Medicinal Chemistry · doi:10.2174/0929867325666171222163645 · Cited by 90 · see citing works
Downing, L. J., Caprio, T. V., & Lyness, J. M. (2013) · Current Psychiatry Reports · doi:10.1007/s11920-013-0365-4 · Cited by 90 · see citing works
Pimavanserin: Potential Treatment For Dementia-Related Psychosis
Cummings, J. L., Ballard, C. G., Tariot, P. N., Owen, R., Foff, E. P., Youakim, J. M., Norton, J., & Stankovic, S. (2018) · The Journal of Prevention of Alzheimer s Disease · doi:10.14283/jpad.2018.29 · Cited by 89 · see citing works
“Pimavanserin was developed on the basis of the observation that antagonism of the 5-HT2A receptor is the common feature of most approved and efficacious APs (26).”
InfluentialDoing damage in delirium: the hazards of antipsychotic treatment in elderly people
Inouye, S. K., Marcantonio, E. R., & Metzger, E. D. (2014) · The Lancet Psychiatry · doi:10.1016/s2215-0366(14)70263-9 · Cited by 88 · see citing works
“Increased risks have been demonstrated for potentially fatal complications including stroke, seizures, venous thromboembolism, QT-prolongation and ventricular arrhythmias (10, 14-16).”
Bruni, G. N., Lakhani, P., & Kokel, D. (2014) · Frontiers in Pharmacology · doi:10.3389/fphar.2014.00153 · Cited by 87 · see citing works
“How do we know when a drug is an antipsychotic or an antidepressant (Maher et al., 2011)?”
BackgroundComparative mortality risks of antipsychotic medications in community-dwelling older adults
Gerhard, T., Huybrechts, K. F., Olfson, M., Schneeweiß, S., Bobo, W. V., Doraiswamy, P. M., Devanand, D. P., Lucas, J. A., Huang, C. Y., Malka, E. S., et al. (2013) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.112.122499 · Cited by 86 · see citing works
Schneider‐Thoma, J., Efthimiou, O., Huhn, M., Krause, M., Reichelt, L., Röder, H., Davis, J. M., Salanti, G., & Leucht, S. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30177-9 · Cited by 80 · see citing works
The Growing Prevalence of Type 2 Diabetes: Increased Incidence or Improved Survival?
Maruthur, N. M. (2013) · Current Diabetes Reports · doi:10.1007/s11892-013-0426-4 · Cited by 82 · see citing works
“Similarly, common medications for chronic disease, such as atypical antipsychotics, increase weight [60, 61] and may increase diabetes risk.”
BackgroundInteractions between antiepileptics and second-generation antipsychotics
de León, J., Santoro, V., D’Arrigo, C., & Spina, E. (2012) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425255.2012.660918 · Cited by 78 · see citing works
“2 SGAP pharmacodynamics Figure 4 summarizes the SGAP mechanism of action, explaining their efficacy in schizophrenia, other psychoses and other psychiatric disorders [6,37-42].”
BackgroundUse of Antipsychotic Medications in Pediatric Populations: What do the Data Say?
Penfold, R. B., Stewart, C. C., Hunkeler, E. M., Madden, J. M., Cummings, J. R., Owen‐Smith, A. A., Rossom, R. C., Lu, C. Y., Lynch, F. L., Waitzfelder, B. E., et al. (2013) · Current Psychiatry Reports · doi:10.1007/s11920-013-0426-8 · Cited by 76 · see citing works
Safety of Low Doses of Quetiapine When Used for Insomnia
Coe, H. V., & Hong, I. S. (2012) · Annals of Pharmacotherapy · doi:10.1345/aph.1q697 · Cited by 75 · see citing works
Potential drug–drug interactions in Alzheimer patients with behavioral symptoms
Monzani, F., Pasqualetti, G., Tognini, S., Calsolaro, V., & Polini, A. (2015) · Clinical Interventions in Aging · doi:10.2147/cia.s87466 · Cited by 74 · see citing works
Keszycki, R. M., Fisher, D. W., & Dong, H.-X. (2019) · Frontiers in Pharmacology · doi:10.3389/fphar.2019.01109 · Cited by 62 · see citing works
Yunusa, I. U., & Helou, M. L. E. (2020) · Frontiers in Pharmacology · doi:10.3389/fphar.2020.00596 · Cited by 73 · see citing works
Metabolic syndrome and obsessive–compulsive disorder: a naturalistic Italian study
Albert, U., Aguglia, A., Chiarle, A., Bogetto, F., & Maina, G. (2012) · General Hospital Psychiatry · doi:10.1016/j.genhosppsych.2012.10.004 · Cited by 73 · see citing works
“No study, to our knowledge, investigated the prevalence of MetS among subjects with OCD, despite the fact that antipsychotic augmentation of SRI is one of the most effective and studied strategies in resistant OCD [36-38].”
BackgroundCioltan, H., Alshehri, S. O., Howe, C. L., Lee, J. K., Fain, M. J., Eng, H. J., Schachter, K. A., & Mohler, J. M. (2017) · BMC Geriatrics · doi:10.1186/s12877-017-0428-1 · Cited by 73 · see citing works
“Adverse health outcomes associated with APM use in the elderly population include increased risk of falls, hospitalizations, cerebrovascular events, sudden cardiac death, and mortality [15].”
BackgroundAn update on the advancements in the treatment of agitation in Alzheimer’s disease
Porsteinsson, A. P., & Antonsdottir, I. M. (2017) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2017.1307340 · Cited by 67 · see citing works
“For decades, antipsychotics have been the pragmatic mainstay of treatment despite their limited efficacy, and history of adverse events outweighing potential benefits including FDA black box warnings [10].”
BackgroundNeuropsychiatric Symptoms in Dementia: Considerations for Pharmacotherapy in the USA
Phan, S. V., Osae, S. P., Morgan, J. C., Inyang, M., & Fagan, S. C. (2019) · Drugs in R&D · doi:10.1007/s40268-019-0272-1 · Cited by 67 · see citing works
Off-Label Use of Atypical Antipsychotics
McKean, A., & Monasterio, E. (2012) · CNS Drugs · doi:10.2165/11632030-000000000-00000 · Cited by 66 · see citing works
Antipsychotic Use Among Nursing Home Residents
Briesacher, B. A., Tjia, J., Field, T. S., Peterson, D., & Gurwitz, J. H. (2013) · JAMA · doi:10.1001/jama.2012.211266 · Cited by 65 · see citing works
“To the Editor: The prescribing of antipsychotic medications persists at high levels in US nursing homes (NHs) despite extensive data demonstrating marginal clinical benefits and serious adverse effects, including death.(1,2) However, imprecise and outdated data have limited the understanding of the current state of an…”
BackgroundChiu, Y., Bero, L. A., Hessol, N. A., Lexchin, J., & Harrington, C. A. (2015) · Health Policy · doi:10.1016/j.healthpol.2015.02.014 · Cited by 65 · see citing works
More action needed: Psychotropic prescribing in Australian residential aged care
Westbury, J. L., Gee, P. R., Ling, T. R., Kitsos, A. R., & Peterson, G. M. (2018) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/0004867418758919 · Cited by 65 · see citing works
Caregiver perspectives about using antipsychotics and other medications for symptoms of dementia
Kerns, J. W., Winter, J. D., Winter, K. M., Kerns, C. C., & Etz, R. S. (2018) · The Gerontologist · doi:10.1093/geront/gnx042 · Cited by 62 · see citing works
“Of medications, antipsychotics have the best evidence for management of agitated and psychotic symptoms in dementia, though the reported benefit is modest: between one in four and one in three patients show improvement (Maher et al., 2011; Sink et al., 2005).”
BackgroundAripiprazole in the treatment of Alzheimer's disease
Deyn, P. P. D., Drenth, A. F. J., Kremer, B. P. H., Voshaar, R. C. O., & Dam, D. V. (2013) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2013.764989 · Cited by 62 · see citing works
“has led to off-label uses as well, including treatment of schizophrenia in children, treatment of dementia-related psychosis in geriatric patients and treatment of other behavior problems [10,11].”
BackgroundHoward, R. J., Cort, E., Bradley, R., Harper, E., Kelly, L. J., Bentham, P., Ritchie, C. W., Reeves, S., Fawzi, W., Livingston, G., et al. (2018) · The Lancet Psychiatry · doi:10.1016/s2215-0366(18)30141-x · Cited by 62 · see citing works
Ruths, S., Sørensen, P. H., Kirkevold, Ø., Husebo, B. S., Krüger, K., Halvorsen, K. H., & Selbæk, G. (2012) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.3902 · Cited by 60 · see citing works
“Conventional and atypical agents provide only small benefits for neuropsychiatric symptoms but appear to equally increase the risk of death (Maher et al., 2011).”
BackgroundPlasencia-García, B. O., Rodríguez-Menéndez, G., Rico-Rangel, M. I., Rubio-García, A., Torelló-Iserte, J., & Crespo‐Facorro, B. (2021) · Psychopharmacology · doi:10.1007/s00213-020-05716-4 · Cited by 61 · see citing works
Chow, R. T. S., Whiting, D., Favril, L., Ostinelli, E. G., Cipriani, A., & Fazel, S. (2023) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2023.105454 · Cited by 59 · see citing works
O’Dwyer, M., Peklar, J., Mulryan, N., McCallion, P., McCarron, M., & Henman, M. C. (2017) · Journal of Intellectual Disability Research · doi:10.1111/jir.12391 · Cited by 60 · see citing works
Evaluation and Management of the Elderly Patient Presenting with Cognitive Complaints
Hildreth, K. L., & Church, S. D. (2014) · Medical Clinics of North America · doi:10.1016/j.mcna.2014.11.006 · Cited by 60 · see citing works
Psychopharmacology of chronic pain: a focus on antidepressants and atypical antipsychotics
Khouzam, H. R. (2016) · Postgraduate Medicine · doi:10.1080/00325481.2016.1147925 · Cited by 59 · see citing works
“approved indications, it is recommended for clinicians not to prescribe the atypical antipsychotics as first line treatment for chronic pain [79] as weight gain in particular could also”
BackgroundAlbert, U., Carmassi, C., Cosci, F., De Cori, D., Di Nicola, M., Ferrari, S., Poloni, N., Tarricone, I., & Fiorillo, A. (2016) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000127 · Cited by 58 · see citing works
“Olanzapine is possibly effective in PTSD both as monotherapy and as adjunctive treatment in resistant patients.”
BackgroundInfluentialAljuhani, A., Ahmed, H. E. A., Ihmaid, S. K., Omar, A. M., Althagfan, S. S., Alahmadi, Y. M., Ahmad, I., Patel, H., Ahmed, S., Almikhlafi, M. A., et al. (2022) · RSC Advances · doi:10.1039/d2ra04015h · Cited by 58 · see citing works
Role of Atypical Antipsychotics in the Treatment of Generalized Anxiety Disorder
Hershenberg, R., Grös, D. F., & Brawman‐Mintzer, O. (2014) · CNS Drugs · doi:10.1007/s40263-014-0162-6 · Cited by 59 · see citing works
The Psychoactive Effects of Psychiatric Medication: The Elephant in the Room
Moncrieff, J., Cohen, D., & Porter, S. (2013) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2013.845328 · Cited by 55 · see citing works
“The ability to flatten emotions may explain why neuroleptics are distinguished from placebo in trials of depression (Robertson & Trimble 1982), and this, combined with their sedative effects, would also explain why many people find them helpful in anxiety (Maher et al. 2011).”
BackgroundDennis, M., Shine, L., John, A. M., Marchant, A. L., McGregor, J., Lyons, R. A., & Brophy, S. T. (2017) · Neurology and Therapy · doi:10.1007/s40120-016-0060-6 · Cited by 56 · see citing works
Mueller, C., John, C., Perera, G., Aarsland, D., Ballard, C. G., & Stewart, R. J. (2020) · European Journal of Epidemiology · doi:10.1007/s10654-020-00643-2 · Cited by 56 · see citing works
Jin, H., Shih, P.-A. B., Golshan, S., Mudaliar, S. R. D., Henry, R. R., Glorioso, D., Arndt, S. V., KRAEMER, H. C., & Jeste, D. V. (2012) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.12m08001 · Cited by 53 · see citing works
Emerging drugs for schizophrenia: an update
Köster, L.-S., Carbon, M., & Correll, C. U. (2014) · Expert Opinion on Emerging Drugs · doi:10.1517/14728214.2014.958148 · Cited by 52 · see citing works
“Additionally, off-label prescribing for aggression associated with disruptive behavior disorders or dementia, obsessive compulsive disorder, anxiety disorders, post-traumatic stress disorder and insomnia [80] further increased sales of agents developed originally as antipsychotics for schizophrenia.”
BackgroundSerotonin in antipsychotic drugs action
Amato, D. (2014) · Behavioural Brain Research · doi:10.1016/j.bbr.2014.07.025 · Cited by 52 · see citing works
Use of Antipsychotics Among Older Residents in VA Nursing Homes
Gellad, W. F., Aspinall, S. L., Handler, S. M., Stone, R. A., Castle, N. G., Semla, T. P., Good, C. B., Fine, M. J., Dysken, M. W., & Hanlon, J. T. (2012) · Medical Care · doi:10.1097/mlr.0b013e31825fb21d · Cited by 52 · see citing works
Buckley, P. F. (2012) · Yearbook of Psychiatry and Applied Mental Health · doi:10.1016/j.ypsy.2012.07.016 · Cited by 52 · see citing works
Gordon, S. E., Dufour, A. B., Monti, S. M., Mattison, M. L. P., Catic, A., Thomas, C. P., & Lipsitz, L. A. (2016) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2016.03.002 · Cited by 52 · see citing works
Yasue, I., Matsunaga, S., Kishi, T., Fujita, K., & Iwata, N. (2016) · Journal of Alzheimer s Disease · doi:10.3233/jad-150818 · Cited by 50 · see citing works
“Therefore, the potential benefits must be evaluated against these risks [9, 10].”
A Systematic Review of Atypical Antipsychotics in Chronic Pain Management
Jimenez, X. F., Sundararajan, T., & Covington, E. C. (2017) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000000567 · Cited by 50 · see citing works
Valproate preparations for agitation in dementia
Baillon, S. F., Narayana, U., Luxenberg, J. S., & Clifton, A. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003945.pub4 · Cited by 50 · see citing works
- 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 › 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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