Autism Mental and Behavioural Disorders Childhood autism
Conditions
Interventions
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 o
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 antidepressants. Individuals prescribed these medications wishing to participate could do so after a washout period of 8 weeks 2. Prescribed an irreversible monoamine oxidase inhibitor (phenelzine, isocarboxazid or tranylcympromine) or pimozide in the preceding 8 weeks 3. Diagnosis of moderate-severe intellectual disability (ID). People who have up to mild ID will be eligible. For the purpose of this study, a person with known intellectual disability will be considered as having a mild ID if they are able to provide written informed consent, and the ability to understand and answer the study questionnaires with the help of reasonable adjustments, if necessary. 4. Inability to provide informed consent and complete study assessments/questionnaires 5. History of bipolar disorder, manic or hypomanic episodes, or psychosis 6. Currently uncontrolled epilepsy 7. Known alcohol or drug use problem 8. Known allergies to sertraline or placebo/excipients 9. Currently enrolled in another RCT 10. Women who are pregnant, are planning pregnancy during the trial period, or breastfeeding 11. Severe liver impairment 12. Bleeding disorders such as such as haemophilia, Christmas disease and von Willebrands disease, as well as those with past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders 13. History of long QT syndrome or Torsade de Pointes 14. Swallowing difficulties or inability to take medication in capsule form 15. Currently using St John's Wort
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety measured using Generalised Anxiety Disorder Assessment (GAD-7) anxiety score at baseline and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effects reported using the Modified Toronto side effects scale and open-ended questions (including suicidality item) at baseline, 1, 2, 4, 8, 12, 16, 24, 36 and 52 weeks 2. Response to treatment defined as a 50% reduction in GAD-7 score at baseline, 1, 2, 4, 8, 12, 16, 24, 36 and 52 weeks 3. Patient reported effect of medication on symptoms measured using study-specific questionnaire at 1, 2, 4, 8, 12, 16, 24, 36 and 52 weeks 4. Social anxiety measured using Social Phobia Inventory (SPIN) at baseline, 16, 24 and 52 weeks 5. Obsessive compulsive symptoms measured using Obsessive Compulsory Inventory Revised (OCI-R) at baseline, 16, 24 and 52 weeks 6. Panic attacks measured using Brief Patient Health Questionnaire (PHQ) from Primary Care Evaluation of Mental Disorders (PRIME-MD) at baseline, 16, 24 and 52 weeks 7. Repetitive behaviours measured using Adult Repetitive Behaviours Questionnaire-2 (RBQ-2A) at baseline, 16, 24 and 52 weeks 8. Depressive symptoms measured using Patient Health Questionnaire-9 (PHQ-9) at baseline, 16, 24 and 52 weeks 9. Functioning and disability measured using World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at baseline, 16, 24 and 52 weeks 10. Health-related quality of life measured using EQ-5D-5L questionnaire at baseline, 12, 16, 24 and 52 weeks 11. Carer burden and health-related quality of life measured using Caregiver Burden Scale, Carer Experience Scale (CES) and EQ-5D-5L questionnaire at baseline, 16, and 52 weeks 12. Adherence to the study medication measured using study-specific questionnaire (adapted from GENPOD and PANDA trials) at 1, 2, 4, 8, 12, 16, 24, 36 and 52 weeks 13. The cost-effectiveness of sertraline treatment for anxiety in adults with a diagnosis of autism measured using EQ-5D-5L (to calculate QALYs) and study-specific patient resource use questionnaire at 24 and 52 weeks 14. Participants’ acceptability, experiences of, and adherence to, study processes and treatment, measured usi | — |
Countries
Australia, England, United Kingdom
Contacts
Public ContactLeonora Cotton
Outcome results
None listed