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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Sertraline | Study protocol

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

Authors: Dheeraj Rai, Doug Webb, Amanda Lewis, Leonora Cotton, Jade Eloise Norris, Regi Alexander, David S. Baldwin, Traolach Brugha, Madeleine Cochrane, Maria Chiara Del Piccolo, Emma J. Glasson, Katherine K. Hatch, David Kessler, Peter E. Langdon, Helen Leonard, Stephanie J. MacNeill, Nicola Mills, Maximiliano Vazquez Morales, Zoe Morgan, Raja Mukherjee, Alba X. Realpe, Ailsa Russell, Sergio Starkstein, Jodi Taylor, Nicholas Turner, Joanna Thorn, Jack Welch, Nicola Wiles, on behalf of the STRATA autistic advisory group

Published in: Trials | Issue 1/2024

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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.
Appendix
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Metadata
Title
Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial
Authors
Dheeraj Rai
Doug Webb
Amanda Lewis
Leonora Cotton
Jade Eloise Norris
Regi Alexander
David S. Baldwin
Traolach Brugha
Madeleine Cochrane
Maria Chiara Del Piccolo
Emma J. Glasson
Katherine K. Hatch
David Kessler
Peter E. Langdon
Helen Leonard
Stephanie J. MacNeill
Nicola Mills
Maximiliano Vazquez Morales
Zoe Morgan
Raja Mukherjee
Alba X. Realpe
Ailsa Russell
Sergio Starkstein
Jodi Taylor
Nicholas Turner
Joanna Thorn
Jack Welch
Nicola Wiles
on behalf of the STRATA autistic advisory group
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07847-3

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