Can a target trial estimate the side effects of antidepressants in autistic adults?

Theme Mental health

Workstream Biological interventions, trial recruitment and safety

Status: This project is ongoing

Many autistic people experience poor mental health.

The results of past research into treatments for mental health problems might not apply to autistic people. For example, medication for mental health problems may affect autistic people differently.

Randomised controlled trials are generally considered the best way to assess medications and other treatments. In this type of study, people are randomly assigned to two (or more) groups to test a specific drug, treatment or other intervention. One group is given the drug, treatment or intervention being tested. A second group can be given an alternative treatment, a dummy (placebo) or no treatment at all.

There are very few randomised controlled trials of treatments for mental health problems in autistic people.

An alternative approach is a target trial. This is a trial that aims to copy, as closely as possible, the structure of a randomised controlled trial, but using data that is already available rather than groups of volunteers.

Project aims

In this project, we aim to:

  • Design a target trial to assess the side effects autistic people experience when taking the antidepressant sertraline, using data routinely collected by GPs
  • Compare our results with the results of a full-scale placebo controlled randomised controlled trial called STRATA, which is already being carried out

What we hope to achieve

Our results will demonstrate whether a target trial design can produce similar results to a full-scale randomised controlled trial. If it can, target trials could be used to assess how other medicines affect autistic people. This could help doctors made better-informed decisions when prescribing medicines to autistic people.