CompletedNot ApplicableInterventional

Sertraline for anxiety in adults with a diagnosis of autism

Anxiety is common among autistic adults and can have a major impact on daily life. Doctors frequently prescribe a medication called sertraline to help treat anxiety. Even so, most research on sertraline has involved non-autistic people, so we do not fully understand its effects or side effects in autistic adults. The STRATA study wants to find out if sertraline is truly effective and safe for autistic people with anxiety. Participants are randomly chosen to take either sertraline capsules or a placebo (an identical dummy capsule with no active medicine) for up to one year. The entire study is run remotely. Study medication is delivered to your home by post, and check-ins happen via video call, phone call, text, or email. You will also fill in questionnaires about your wellbeing, receiving a £10 gift voucher for each one you complete.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Bristol

Enrolment target

306

Start

01 Jun 2021

Estimated completion

26 Oct 2023

Autism

What is this study about?

Anxiety is a common challenge for many autistic adults. Feeling constantly worried, tense, or overwhelmed can make daily routines, social interactions, and work very difficult. Doctors often prescribe a medication called sertraline to help reduce these symptoms. While sertraline is widely used in the NHS, almost all the research behind it was carried out with non-autistic people.

Autistic adults can experience both the benefits and side effects of medications differently. Because of this, doctors and patients currently have to make decisions without clear evidence about whether sertraline is the right choice. This clinical trial was designed with the help of an advisory group of autistic adults to bridge this knowledge gap and ensure the research is comfortable and respectful for participants.

By comparing sertraline against a placebo (an inactive dummy capsule), researchers can measure whether the medicine genuinely relieves anxiety and improves quality of life over 12 months. The results will help create clear, evidence-based prescribing guidelines so autistic adults in the future receive the most effective care.

Key takeaways

Tests whether the drug sertraline effectively treats anxiety in autistic adults.
Open to UK adults aged 18 and over with an autism diagnosis.
Completely remote: capsules are posted to you and catch-ups happen by phone, video, or message.
You will take either sertraline or a dummy capsule (placebo) for up to one year.
You will receive a £10 gift voucher for each of the four study surveys you complete.

Who may be eligible?

To be eligible, you must be 18 years or older with a diagnosis of autism, Asperger syndrome, or an autism spectrum condition. You should be experiencing anxiety that you are open to treating with medication, and you must be able to give your consent and fill out study questionnaires either online or on paper.

You cannot take part if you are currently taking antidepressants (or have taken them regularly in the last 8 weeks) or if you use St John's Wort. You will also be unable to join if you have certain health conditions, including bipolar disorder, psychosis, uncontrolled epilepsy, severe liver disease, bleeding disorders, or certain heart problems.

Finally, the study is not suitable for anyone who is pregnant, planning a pregnancy, or breastfeeding. You must also be able to swallow capsules without difficulty and cannot have a moderate or severe learning disability that makes answering the surveys too difficult.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have a formal diagnosis of autism or Asperger syndrome.
I feel anxious and am willing to try medication for it.
I have not taken antidepressants or St John's Wort in the past 8 weeks.
I am able to swallow capsules and am not pregnant or breastfeeding.
I can comfortably complete surveys online or on paper.

Answer every question to see your result.

What does participation involve?

Taking part lasts for up to one year and is done entirely from your home, meaning there is no need to travel to hospital appointments. If you join, you will be randomly assigned to take either sertraline capsules or inactive placebo capsules once a day. These are posted directly to your home. Please note that the capsules may contain gelatine.

A member of the study team will check in with you briefly at weeks 1 to 2, 4, 8, 12, and 36. You can choose whether these chats happen by telephone, video call, text message, or email. You will also complete questionnaires about your symptoms and health at the start, and then at 4 months, 6 months, and 1 year. Each survey takes around an hour to finish, and you can take breaks whenever you need. As a thank-you for your time, you will receive a £10 gift voucher for each completed questionnaire.

Potential risks and benefits

You may find that your anxiety improves during the study, although this cannot be guaranteed, particularly if you are given the dummy pill. However, your feedback will directly help improve healthcare and prescribing choices for other autistic adults in the future. Possible risks include common side effects of sertraline (such as mild stomach upset or changes in sleep) or feeling tired after answering questions. Taking part does not replace your usual healthcare, and you can withdraw from the study at any time without giving a reason and without affecting your normal NHS treatment.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Avon and Wiltshire Mental Health Partnership NHS Trust
City only
Bath, England
Leicestershire Partnership NHS Trust
City only
Leicester, England
Nottinghamshire Healthcare NHS Foundation Trust
City only
Nottingham, England
Coventry and Warwickshire Partnership NHS Trust
City only
Coventry, England
Gloucestershire Health and Care NHS Foundation Trust
City only
Gloucester, England
Surrey and Borders Partnership NHS Foundation Trust
Unverified
Leatherhead, England
Norfolk Community Health and Care NHS Trust
Unverified
Norwich, England
Hertfordshire Partnership University NHS Foundation Trust
Unverified
Hatfield, England
Black Country Healthcare NHS Foundation Trust
Unverified
Dudley, England
Leeds and York Partnership NHS Foundation Trust
Unverified
Leeds, England
Camden and Islington NHS Foundation Trust
Unverified
London, England
Fremantle Hospital
Unverified
Fremantle WA, Australia

Common questions

Will I definitely receive the real medication?

No. A computer randomly decides whether you receive sertraline or a dummy pill (placebo). Neither you nor the researchers will know which one you are taking until the study ends.

Do I need to visit a clinic or hospital?

No. The study is completely remote. Medications are sent by post, and all appointments take place over the phone, video call, email, or text.

Are the study capsules suitable for vegans?

The capsules may contain animal gelatine, so they might not be suitable for vegans or those who avoid gelatine for religious reasons.

Can I still see my usual GP while taking part?

Yes. The study does not replace your standard medical care. You should continue to see your GP or mental health team for any physical or mental health needs.

What happens if I change my mind?

You are free to leave the trial at any point. You do not have to provide a reason, and your regular NHS medical care will not be affected.

How to find out more

Leonora Cotton

strata-rct@bristol.ac.uk +44 117 455 5738 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.