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

被引：0

作者：

Rai, Dheeraj ^{[1
,2
,3
]}

Webb, Doug ^{[1
,4
]}

Lewis, Amanda ^{[1
,4
]}

Cotton, Leonora ^{[1
,4
]}

Norris, Jade Eloise ^{[1
,4
]}

Alexander, Regi ^{[5
]}

Baldwin, David S. ^{[6
]}

Brugha, Traolach ^{[7
]}

Cochrane, Madeleine ^{[1
,4
]}

Del Piccolo, Maria Chiara ^{[8
]}

Glasson, Emma J. ^{[9
,10
]}

Hatch, Katherine K. ^{[10
]}

Kessler, David ^{[1
,2
]}

Langdon, Peter E. ^{[11
,12
]}

Leonard, Helen ^{[9
,10
]}

Macneill, Stephanie J. ^{[1
,2
,4
]}

Mills, Nicola ^{[1
,2
]}

Morales, Maximiliano Vazquez ^{[1
,4
]}

Morgan, Zoe ^{[7
]}

Mukherjee, Raja ^{[8
]}

Realpe, Alba X. ^{[1
,2
,4
]}

Russell, Ailsa ^{[13
]}

Starkstein, Sergio ^{[10
]}

Taylor, Jodi ^{[1
,4
]}

Turner, Nicholas ^{[1
,4
]}

Thorn, Joanna ^{[1
,4
]}

Welch, Jack ^{[14
]}

Douglas, Sarah

Hale, Peter

O'Brien, Sarah

Walker, Amy

Wiles, Nicola ^{[1
,2
]}

机构：

[1] Univ Bristol, Populat Hlth Sci, Bristol, England

[2] NIHR Bristol Biomed Res Ctr, Bristol, England

[3] Avon & Wiltshire Partnership Mental Hlth NHS Trust, Bath, England

[4] Univ Bristol, Bristol Trials Ctr, Bristol, England

[5] Hertfordshire Partnership NHS Fdn Trust, Hatfield, England

[6] Univ Southampton, Fac Med, Clin & Expt Sci, Southampton, England

[7] Univ Leicester, Leicester, England

[8] Surrey & Borders Partnership NHS Fdn Trust, Leatherhead, England

[9] Univ Western Australia, Telethon Kids Inst, Perth, Australia

[10] Univ Western Australia, Med Sch, Discipline Psychiat, Perth, Australia

[11] Univ Warwick, Ctr Res Intellectual & Dev Disabil, Coventry, England

[12] Coventry & Warwickshire Partnership NHS Trust, Coventry, England

[13] Univ Bath, Ctr Appl Autism Res, Dept Psychol, Bath, England

[14] Dorset Cty Hosp NHS Fdn Trust, Dorchester, England

来源：

TRIALS | 2024年 / 25卷 / 01期

基金：

英国医学研究理事会; 美国国家卫生研究院;

关键词：

Autism; Asperger; Anxiety; Adults; Antidepressant; Mental health; Sertraline; Selective Serotonin reuptake inhibitors; Placebo; Randomised controlled trial; SPECTRUM DISORDER; REPETITIVE BEHAVIORS; BRITISH ASSOCIATION; DEPRESSION; SEVERITY; VALIDATION; FLUOXETINE; GUIDELINES; VALIDITY;

D O I：

10.1186/s13063-023-07847-3

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundSelective 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.MethodsSTRATA 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.DiscussionResults 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 registrationISRCTN, ISRCTN15984604. Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021.

引用

页数：20

共 55 条

[21] A Double-Blind Placebo-Controlled Trial of Fluoxetine for Repetitive Behaviors and Global Severity in Adult Autism Spectrum Disorders [J].