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

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Rai, D., Webb, D., Lewis, A., Cotton, L., Norris, J. E., Alexander, R., Baldwin, D. S., Brugha, T., Cochrane, M., Del Piccolo, M. C., Glasson, E. J., Hatch, K. K., Kessler, D., Langdon, P. E., Leonard, H., MacNeill, S. J., Mills, N., Morales, M. V., Morgan, Z.,..., & Wiles, N. (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(1), 37-37. https://doi.org/10.1186/s13063-023-07847-3

Publication date: 11 Jan 2024 Added to AutiHub: 12 Sep 2026 Type: Article Article language: English
Publisher source (DOI) Full text OpenAlex source

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Authors

Publication authors
33
Publication authors identified as autistic
3 / 33 (9.1%)
  1. Dheeraj Rai
  2. Doug Webb
  3. Amanda Lewis
  4. Leonora Cotton
  5. Jade Eloise Norris
  6. Regi Alexander
  7. David S. Baldwin
  8. Traolach Brugha
  9. Madeleine Cochrane
  10. Maria Chiara Del Piccolo
  11. Emma J. Glasson
  1. Katherine K. Hatch
  2. David Kessler
  3. Peter E. Langdon
  4. Helen Leonard
  5. Stephanie J. MacNeill
  6. Nicola Mills
  7. Maximiliano Vazquez Morales
  8. Zoe Morgan
  9. Raja Mukherjee
  10. Alba Realpe
  11. Ailsa Russell
  1. Sergio Starkstein
  2. Jodi Taylor
  3. Nicholas Turner
  4. Joanna Thorn
  5. Jack Welch
  6. on behalf of the STRATA autistic advisory group
  7. Sarah Douglas *
  8. Peter Hale
  9. Sarah O’Brien *
  10. Amy Walker *
  11. Nicola Wiles

Abstract

Abstract 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.

Bibliography cited by this reference

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Cited bibliography overview

These indicators describe the bibliography cited by this publication. An author name is counted each time it appears in one cited reference, so the same person can be counted more than once. Names not yet linked to an author already present in AutiHub are treated as unknown, not as non-autistic. Last computed: 12 Sep 2026 18:20.

Cited references
57
With a DOI
46
Without a DOI, from raw bibliography text
11
3 / 57 (5.3%) cited references include at least one author identified as autistic.
References with data to complete
10 / 57 (17.5%)
References with detected author names
49 / 57 (86.0%)
Without detected author names
8
Without a structured title
10
Without a stable identifier
11
References with raw author names still to review
8
References with external metadata lookup issues
0
These indicators apply to cited references displayed on this page, after technical duplicates have been merged. A reference without a DOI can still support author statistics when a title and author names are available.
Author names detected in the cited bibliography
345
From DOI or external metadata
345
From validated raw bibliography text
0
Raw names already validated
0
Raw names still to review
10
91 / 345 (26.4%) names are linked to an author already present in AutiHub. 254 / 345 (73.6%) names are not yet linked.
Names linked to a person identified as autistic
5 / 345 (1.4%)
Calculated across all author names detected in the cited bibliography. Among names linked to an author already present in AutiHub: 5 / 91 (5.5%). Distinct people identified as autistic: 4 / 291 (1.4%).
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