Sertraline for anxiety in adults with a diagnosis of autism (STRATA): Study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial

Rai, Dheeraj, Webb, Doug, Lewis, Amanda, Cotton, Leonora, Norris, Jade Eloise, Alexander, Regi, Baldwin, David S., Brugha, Traolach, Cochrane, Madeleine, Del Piccolo, Maria Chiara, Glasson, Emma J., Hatch, Katherine K., Kessler, David, Langdon, Peter E. ORCID:, Leonard, Helen, MacNeill, Stephanie J., Mills, Nicola, Morales, Maximiliano Vazquez, Morgan, Zoe, Mukherjee, Raja, Realpe, Alba X., Russell, Ailsa, Starkstein, Sergio, Taylor, Jodi, Turner, Nicholas, Thorn, Joanna, Welch, Jack and Wiles, Nicola and on behalf of the STRATA autistic advisory group (2024) Sertraline for anxiety in adults with a diagnosis of autism (STRATA): Study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial. Trials, 25. ISSN 1745-6215

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Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. Methods: STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1–2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. Discussion: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. Trial registration: ISRCTN, ISRCTN15984604 . Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021.

Item Type: Article
Additional Information: Funding Information: This project was funded by the NIHR Research Health Technology Assessment Programme (NIHR127337) and is also supported by the NIHR Bristol Biomedical Research Centre. The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health and Social Care. The Australian component of this study is funded by the NHMRC (GNT1171206). The contents of the published material are solely the responsibility of the individual authors and do not reflect the views of NHMRC. The funders have no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
Uncontrolled Keywords: adults,antidepressant,anxiety,asperger,autism,mental health,placebo,randomised controlled trial,selective serotonin reuptake inhibitors,sertraline,medicine (miscellaneous),pharmacology (medical),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2701
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Depositing User: LivePure Connector
Date Deposited: 04 Mar 2024 18:27
Last Modified: 04 Mar 2024 18:28
DOI: 10.1186/s13063-023-07847-3


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