Amisulpride for very late-onset schizophrenia-like psychosis: The ATLAS three-arm RCT

Journal article


Howard, Robert, Cort, Elizabeth, Bradley, Rosie, Harper, Emma, Kelly, Linda, Bentham, Peter, Ritchie, Craig, Reeves, Suzanne, Fawzi, Waleed, Livingston, Gill, Sommerlad, Andrew, Oomman, Sabu, Nazir, Ejaz, Nilforooshan, Ramin, Barber, Robert, Fox, Chris, Macharouthu, Ajay, Ramachandra, Pranathi, Pattan, Vivek, ... Gray, Richard. (2018). Amisulpride for very late-onset schizophrenia-like psychosis: The ATLAS three-arm RCT. Health Technology Assessment. 22(67), pp. 1 - 60. https://doi.org/10.3310/hta22670
AuthorsHoward, Robert, Cort, Elizabeth, Bradley, Rosie, Harper, Emma, Kelly, Linda, Bentham, Peter, Ritchie, Craig, Reeves, Suzanne, Fawzi, Waleed, Livingston, Gill, Sommerlad, Andrew, Oomman, Sabu, Nazir, Ejaz, Nilforooshan, Ramin, Barber, Robert, Fox, Chris, Macharouthu, Ajay, Ramachandra, Pranathi, Pattan, Vivek, Sykes, John, Curran, Valerie, Katona, Cornelius, Dening, Tom, Knapp, Martin, Romeo, Renee and Gray, Richard
Abstract

Background: Very late-onset (aged ≥ 60 years) schizophrenia-like psychosis (VLOSLP) occurs frequently but no placebo-controlled, randomised trials have assessed the efficacy or risks of antipsychotic treatment. Most patients are not prescribed treatment. Objectives: The study investigated whether or not low-dose amisulpride is superior to placebo in reducing psychosis symptoms over 12 weeks and if any benefit is maintained by continuing treatment thereafter. Treatment safety and cost-effectiveness were also investigated. Design: Three-arm, parallel-group, placebo-controlled, double-blind, randomised controlled trial. Participants who received at least one dose of study treatment were included in the intention-to-treat analyses. Setting: Secondary care specialist old age psychiatry services in 25 NHS mental health trusts in England and Scotland. Participants: Patients meeting diagnostic criteria for VLOSLP and scoring > 30 points on the Brief Psychiatric Rating Scale (BPRS). Intervention: Participants were randomly assigned to three arms in a two-stage trial: (1) 100 mg of amisulpride in both stages, (2) amisulpride then placebo and (3) placebo then amisulpride. Treatment duration was 12 weeks in stage 1 and 24 weeks (later reduced to 12) in stage 2. Participants, investigators and outcome assessors were blind to treatment allocation. Main outcome measures: Primary outcomes were psychosis symptoms assessed by the BPRS and trial treatment discontinuation for non-efficacy. Secondary outcomes were extrapyramidal symptoms measured with the Simpson–Angus Scale, quality of life measured with the World Health Organization’s quality-of-life scale, and cost-effectiveness measured with NHS, social care and carer work loss costs and EuroQol-5 Dimensions. Results: A total of 101 participants were randomised. Ninety-two (91%) participants took the trial medication, 59 (64%) completed stage 1 and 33 (56%) completed stage 2 treatment. Despite suboptimal compliance, improvements in BPRS scores at 12 weeks were 7.7 points (95% CI 3.8 to 11.5 points) greater with amisulpride than with placebo (11.9 vs. 4.2 points; p = 0.0002). In stage 2, BPRS scores improved by 1.1 point in those who continued with amisulpride but deteriorated by 5.2 points in those who switched from amisulpride to placebo, a difference of 6.3 points (95% CI 0.9 to 11.7 points; p = 0.024). Fewer participants allocated to the amisulpride group stopped treatment because of non-efficacy in stages 1 (p = 0.01) and 2 (p = 0.031). The number of patients stopping because of extrapyramidal symptoms and other side effects did not differ significantly between groups. Amisulpride treatment in the base-case analyses was associated with non-significant reductions in combined NHS, social care and unpaid carer costs and non-significant reductions in quality-adjusted life-years (QALYs) in both stages. Including patients who were intensive users of inpatient services in sensitivity analyses did not change the QALY result but resulted in placebo dominance in stage 1 and significant reductions in NHS/social care (95% CI –£8923 to –£122) and societal costs (95% CI –£8985 to –£153) for those continuing with amisulpride. Limitations: The original recruitment target of 300 participants was not achieved and compliance with trial medication was highly variable. Conclusions: Low-dose amisulpride is effective and well tolerated as a treatment for VLOSLP, with benefits maintained by prolonging treatment. Potential adverse events include clinically significant extrapyramidal symptoms and falls. Future work: Trials should examine the longer-term effectiveness and safety of antipsychotic treatment in this patient group, and assess interventions to improve their appreciation of potential benefits of antipsychotic treatment and compliance with prescribed medication. Trial registration: Current Controlled Trials ISRCTN45593573 and EudraCT2010-022184-35. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 67. See the NIHR Journals Library website for further project information.

Year2018
JournalHealth Technology Assessment
Journal citation22 (67), pp. 1 - 60
PublisherNational Coordinating Centre for Health Technology Assessment
ISSN1366-5278
Digital Object Identifier (DOI)https://doi.org/10.3310/hta22670
Scopus EID2-s2.0-85058922242
Page range1 - 60
Publisher's version
File Access Level
Controlled
Place of publicationUnited Kingdom
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Chandni Hindocha, Tom P. Freeman, Meryem Grabski, H. Crudgington, A.C. Davies, J.B. Stroud, Ravi K. Das, Will Lawn, Celia Morgan and H. Valerie Curran. (2018). The effects of cannabidiol on impulsivity and memory during abstinence in cigarette dependent smokers . Scientific Reports. 8(7568), pp. 1-7. https://doi.org/10.1038/s41598-018-25846-2
The acute effects of a dopamine d3 receptor preferring agonist on motivation for cigarettes in dependent and occasional cigarette smokers
Will Lawn, Tom P. Freeman, Katie East, Annie Gaule, Elizabeth R. Aston, M. A P Bloomfield, Ravi K. Das, Celia Morgan and H. Valerie Curran. (2018). The acute effects of a dopamine d3 receptor preferring agonist on motivation for cigarettes in dependent and occasional cigarette smokers. Nicotine and Tobacco Research. 20(7), pp. 800-809. https://doi.org/10.1093/ntr/ntx159
Psilocybin with psychological support improves emotional face recognition in treatment-resistant depression
J.B. Stroud, Tom P. Freeman, Robert Leech, Chandni Hindocha, Will Lawn, D.J. Nutt, H. V. Curran and R. L. Carhart-Harris. (2018). Psilocybin with psychological support improves emotional face recognition in treatment-resistant depression. Psychopharmacology. 235(2), pp. 459-466. https://doi.org/10.1007/s00213-017-4754-y
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up
R. L. Carhart-Harris, M. Bolstridge, C.M.J. Day, J. Rucker, R. Watts, David Erritzoe, M. Kaelen, B. Giribaldi, M. A P Bloomfield, S. Pilling, J.A. Rickard, B. Forbes, A. Feilding, D. Taylor, H. V. Curran and D.J. Nutt. (2018). Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology. 235(2), pp. 399-408. https://doi.org/10.1007/s00213-017-4771-x
Non-dependent and dependent daily cannabis users differ in mental health but not prospective memory ability
Ruth Braidwood, Samantha Mansell, Jon Waldron, Peter Rendell, Sunjeev Kamboj and H. Valerie Curran. (2018). Non-dependent and dependent daily cannabis users differ in mental health but not prospective memory ability. Frontiers in Psychiatry. 9(97), pp. 1-9. https://doi.org/10.3389/fpsyt.2018.00097
Individual and combined effects of acute delta-9-tetrahydrocannabinol and cannabidiol on psychotomimetic symptoms and memory function
Celia Morgan, Tom P. Freeman, Chandni Hindocha, Grainne Schafer, Chelsea Gardner and H. Valerie Curran. (2018). Individual and combined effects of acute delta-9-tetrahydrocannabinol and cannabidiol on psychotomimetic symptoms and memory function. Translational Psychiatry (online). 8(1), pp. 1-10. https://doi.org/10.1038/s41398-018-0191-x
Cannabis Dampens the Effects of Music in Brain Regions Sensitive to Reward and Emotion
Tom P. Freeman, Rebecca A. Pope, Matthew B. Wall, James A. Bisby, Maartje Luijten, Chandni Hindocha, Claire Mokrysz, Will Lawn, Abigail Moss, Michael A. P. Bloomfield, Celia J. A. Morgan, David J. Nutt and H. Valerie Curran. (2018). Cannabis Dampens the Effects of Music in Brain Regions Sensitive to Reward and Emotion. International Journal of Neuropsychopharmacology. 21(1), pp. 21-32. https://doi.org/10.1093/ijnp/pyx082
Cannabidiol reverses attentional bias to cigarette cues in a human experimental model of tobacco withdrawal
Chandni Hindocha, Tom P. Freeman, Meryem Grabsk, Jack B. Stroud, Holly Crudgington, Alan C. Davies, Ravi K. Das, William Lawn, Celia Morgan and H. Valerie Curran. (2018). Cannabidiol reverses attentional bias to cigarette cues in a human experimental model of tobacco withdrawal. Addiction. 113(9), pp. 1696-1705. https://doi.org/10.1111/add.14243
Ketamine treatment for depression : Opportunities for clinical innovation and ethical foresight
Singh, Ilina, Morgan, Celia, Curran, Valerie, Nutt, David, Schlag, Anne and McShane, Rupert. (2017). Ketamine treatment for depression : Opportunities for clinical innovation and ethical foresight. The Lancet Psychiatry. 4(5), pp. 419-426. https://doi.org/10.1016/S2215-0366(17)30102-5
Anatomy of a Joint: Comparing Self-Reported and Actual Dose of Cannabis and Tobacco in a Joint, and How These Are Influenced by Controlled Acute Administration
Chandni Hindocha, Tom P. Freeman and H. Valerie Curran. (2017). Anatomy of a Joint: Comparing Self-Reported and Actual Dose of Cannabis and Tobacco in a Joint, and How These Are Influenced by Controlled Acute Administration. Cannabis and Cannabinoid Research. 2(1), pp. 217-223. https://doi.org/10.1089/can.2017.0024
Acute memory and psychotomimetic effects of cannabis and tobacco both 'joint' and individually: A placebo-controlled trial
Hindocha, Chandni, Freeman, T. P., Xia, J. X., Shaban, Natacha D. C. and Curran, Helen V.. (2017). Acute memory and psychotomimetic effects of cannabis and tobacco both 'joint' and individually: A placebo-controlled trial. Psychological Medicine. 47(15), pp. 2708 - 2719. https://doi.org/10.1017/S0033291717001222
Editorial : Reporting guidelines for psychopharmacology
Steckler, Thomas, Curran, H. Valerie, de Wit, Harriet, Howes, Oliver, Hoyer, Daniel, Lucki, Irwin, Miczek, Klaus A., Morrow, A. Leslie, Price, Lawrence H. and Robbins, Trevor W.. (2016). Editorial : Reporting guidelines for psychopharmacology. Psychopharmacology. 233(7), pp. 1131-1134. https://doi.org/10.1007/s00213-016-4252-7
AKT1 genotype moderates the acute psychotomimetic effects of naturalistically smoked cannabis in young cannabis smokers
Morgan, Celia J. A., Freeman, T. P., Powell, J. and Curran, Helen V.. (2016). AKT1 genotype moderates the acute psychotomimetic effects of naturalistically smoked cannabis in young cannabis smokers. Translational Psychiatry. 6(2), pp. 1 - 6. https://doi.org/10.1038/tp.2015.219
Deconstructing the nature of episodic foresight deficits associated with chronic opiate use
Mercuri, Kimberly, Terrett, Gill, Bailey, Phoebe E., Henry, Julie D., Curran, Helen Valerie and Rendell, Peter G.. (2016). Deconstructing the nature of episodic foresight deficits associated with chronic opiate use. British Journal of Clinical Psychology. 55(4), pp. 401 - 413. https://doi.org/10.1111/bjc.12110
Are adolescents more vulnerable to the harmful effects of cannabis than adults? A placebo-controlled study in human males
Mokrysz, Claire, Freeman, Tom P., Korkki, S., Griffiths, K. and Curran, Helen V.. (2016). Are adolescents more vulnerable to the harmful effects of cannabis than adults? A placebo-controlled study in human males. Translational Psychiatry. 6(11), pp. 1 - 10. https://doi.org/10.1038/tp.2016.225
LSD enhances the emotional response to music
Kaelen, M., Barrett, F. S., Roseman, L., Lorenz, R., Family, N., Bolstridge, M., Curran, Helen V., Feilding, A., Nutt, David J. and Carhart-Harris, R. L.. (2015). LSD enhances the emotional response to music. Psychopharmacology. 232(19), pp. 3607 - 3614. https://doi.org/10.1007/s00213-015-4014-y
Effects of immediate-release opioid on memory functioning: A randomized-controlled study in patients receiving sustained-release opioids
Kamboj, S. K., Conroy, L., Tookman, A., Carroll, E., Jones, L. and Curran, H.. (2014). Effects of immediate-release opioid on memory functioning: A randomized-controlled study in patients receiving sustained-release opioids. European Journal of Pain. 18(10), pp. 1376 - 1384. https://doi.org/10.1002/j.1532-2149.2014.498.x
Effects of ecstasy on cooperative behaviour and perception of trustworthiness: A naturalistic study
Stewart, L. H., Ferguson, B., Morgan, C. J. A., Swaboda, N., Jones, L., Fenton, R., Wall, M. B. and Curran, H.. (2014). Effects of ecstasy on cooperative behaviour and perception of trustworthiness: A naturalistic study. Journal of Psychopharmacology. 28(11), pp. 1001 - 1008. https://doi.org/10.1177/0269881114544775
Prospective memory impairment in long-term opiate users
Terrett, Gillian, McLennan, Skye, Henry, Julie, Biernacki, Kathryn, Mercuri, Kimberly, Curran, Valerie and Rendell, Peter. (2014). Prospective memory impairment in long-term opiate users. Psychopharmacology. 231(13), pp. 2623 - 2632. https://doi.org/10.1007/s00213-014-3432-6
Benzodiazepines: Risks and benefits. A reconsideration
Baldwin, David S., Aitchison, Katherine, Bateson, Alan, Curran, H. Valerie, Davies, Simon, Leonard, Brian, Nutt, David J., Stephens, David N. and Wilson, Sue. (2013). Benzodiazepines: Risks and benefits. A reconsideration. Journal of Psychopharmacology. 27(11), pp. 967 - 971. https://doi.org/10.1177/0269881113503509
Prospective memory and future event simulation in individuals with alcohol dependence
Griffiths, Alison, Hill, Robert, Morgan, Celia, Rendell, Peter Gregory, Karimi, Khashayar, Wanagaratne, Shamil and Curran, Valerie. (2012). Prospective memory and future event simulation in individuals with alcohol dependence. Addiction. 107(10), pp. 1809 - 1816. https://doi.org/10.1111/j.1360-0443.2012.03941.x
Neurocognitive function and schizophrenia-proneness in individuals dependent on ketamine, on high potency cannabis (skunk) or on cocaine
Morgan, Celia, Duffin, S., Hunt, S., Monaghan, L., Mason, O. and Curran, Helen. (2012). Neurocognitive function and schizophrenia-proneness in individuals dependent on ketamine, on high potency cannabis (skunk) or on cocaine. Pharmacopsychiatry. 45(7), pp. 269 - 274. https://doi.org/10.1055/s-0032-1306310