Sertraline for anxiety in adults with a diagnosis of autism
- Conditions
- AutismMental and Behavioural DisordersChildhood autism
- Registration Number
- ISRCTN15984604
- Lead Sponsor
- niversity of Bristol
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38212784/ (added 12/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 318
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety measured using Generalised Anxiety Disorder Assessment (GAD-7) anxiety score at baseline and 16 weeks
- Secondary Outcome Measures
Name Time Method