*STRATA

• Research type

  Research Study

• Full title

  A multicentre double-blind placebo-controlled randomised trial of SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA)

• IRAS ID

  270727

• Contact name

  Dheeraj Rai

• Contact email

  strata-rct@bristol.ac.uk

• Sponsor organisation

  Univeristy of Bristol

• Eudract number

  2019-004312-66

• ISRCTN Number

  ISRCTN15984604

• Duration of Study in the UK

  3 years, 5 months, 30 days

• Research summary

  Anxiety is common in autistic adults and can be more disabling than the core features of autism. Medications for anxiety are often prescribed for autistic adults but their effectiveness or side effects in this population are not well known. Research findings in non-autistic populations may not apply to autistic adults.
  
  This study aims to find out whether the drug sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. Sertraline is a commonly prescribed antidepressant and is also recommended for the treatment of anxiety problems. We will compare the use of sertraline in autistic people with placebo, a non-active identical capsule. We are interested to see whether the treatment improves symptoms of anxiety, enhances quality of life, and is effective in the longer term. We are also interested in understanding side effects of the treatment.

  This trial will be run in five geographical regions in England and Western Australia. Autistic services within the 5 regions will recruit adults with an autism diagnosis and screened for anxiety. We aim to include 306 people who will be allocated at random to receive either sertraline capsules or identical inactive placebo capsules, which they will be asked to take for up to 12 months.
  
  They will be asked to complete questionnaires about themselves, their anxiety, mental health, use of services, and side effects they may experience during the trial. We will interview some participants about their experiences of being in the study and taking the study medications, and their reasons for continuing or withdrawing from the study. Carers will be invited to explore carer burden in a nested sub-study. The results of this trial will help understand whether sertraline is an acceptable treatment and whether it is better or not than placebo in the treatment of anxiety in autistic adults.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  22/SC/0296

• Date of REC Opinion

  1 Feb 2021

• REC opinion

  Further Information Favourable Opinion