A multicentre double-blind placebo-controlled randomised trial of SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA)
Autism
Participants will be randomized to one of two treatment groups: either sertraline (intervention arm) or placebo (control arm). Participants will receive a daily dose of 25 mg encapsulated sertraline or placebo for 2 weeks followed by 2 x 25 mg for 4 weeks. Depending upon tolerability, the prescriber will flexibly increase the dose by 50 mg every 4 weeks to reach the optimal dose. The dose will only be increased if the participant is tolerating it and agrees to try an increased dose, and the prescriber is satisfied that it is appropriate to do so. For example, the dose may go up to a maximum of 200mg by week 14, although it is anticipated that for many participants the optimal dose will be lower (e.g. 50 mg, 100 mg or 150 mg) and reached before this time. Participants will have different treatment schedules depending on their optimal dose. However, in all cases participants shall take medication for up to 52-weeks post-randomisation unless they, or their care team, discontinues medication sooner. After 52-weeks post-randomisation (or if they discontinue medication sooner), participants will complete a downward titration of the study medication for a period of 4 weeks, which involves reduction of medication by 50 mg per week before being returned to standard care. The placebo regimen will be identical.
Current participant inclusion criteria as of 31/03/2022: 1. Aged ≥18 years and have a diagnosis of autism (including autism spectrum disorder/condition or other variations, Asperger syndrome, or pervasive developmental disorder) 2. Experience anxiety for which participants are willing to try treatment with medication 3. Able to complete online or paper-based questionnaires about things such as anxiety, other symptoms, and healthcare usage 4. Able to provide informed consent to take part Previous participant inclusion criteria: 1. Adults aged ≥18 years 2. A diagnosis of autism made by a specialist including those with a co-occurring mild intellectual disability (autism diagnostic terms may include autism/autistic spectrum disorder or other variations, Asperger syndrome/disorder or pervasive developmental disorder) 3. Anxiety as measured by GAD-7 score ≥10
Current participant exclusion criteria as of 24/02/2023: 1. Currently taking medication(s) for depression and/or anxiety at antidepressant doses, or have taken them regularly in the past 8 weeks, or are using St John’s Wort 2. Have a moderate or severe learning disability which means they may not be able to provide informed consent and/or understand and complete the study questionnaires 3. Have/had other mental health conditions with a currently valid diagnosis such as bipolar disorder or psychosis 4. Have epilepsy that is not well controlled 5. Have current problematic use of alcohol or illicit drugs 6. Have allergies to sertraline or placebo 7. Have/had severe liver problems, bleeding disorders, some heart problems 8. Have swallowing difficulties or are unable to take medication in capsule form 9. Taking part in another clinical trial 10. Are pregnant, planning pregnancy during the study period, or breastfeeding Previous participant exclusion criteria as of 31/03/2022 to 24/02/2023: 1. Currently taking medication(s) for depression and/or anxiety, or have taken them in the past 8 weeks, or are using St John’s Wort 2. Have a moderate or severe learning disability which means they may not be able to provide informed consent and/or understand and complete the study questionnaires 3. Have/had other mental health conditions such as bipolar disorder or psychosis 4. Have epilepsy that is not well controlled 5. Have current problematic use of alcohol or illicit drugs 6. Have allergies to sertraline or placebo 7. Have/had severe liver problems, bleeding disorders, some heart problems 8. Have swallowing difficulties or are unable to take medication in capsule form 9. Taking part in another clinical trial 10. Are pregnant, planning pregnancy during the study period, or breastfeeding Previous participant exclusion criteria: 1. Prescribed a serotonergic antidepressant/anxiolytic in preceding 8 weeks - these include SSRI and non-SSRI antidepressants including tricyclic anti