Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000801819
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
25/06/2021
Date last updated
16/11/2023
Date data sharing statement initially provided
25/06/2021
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SerTRaline for AnxieTy in adults with a diagnosis of Autism (STRATA)
A randomised controlled trial.
Scientific title
A multicentre double-blind placebo-controlled randomised trial of SerTRaline for AnxieTy in adults with Autism (STRATA)-Australian component.
Secondary ID [1] 300050 0
Nil known.
Universal Trial Number (UTN)
U1111-1264-9106
Trial acronym
STRATA
Linked study record
The UK component of the study has been registered with ISRCTN (ISRCTN15984604)

Health condition
Health condition(s) or problem(s) studied:
Anxiety 315557 0
Autism 315558 0
Condition category
Condition code
Mental Health 313844 313844 0 0
Anxiety
Mental Health 313845 313845 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project is a two parallel group multi-centre pragmatic randomised controlled trial (RCT) of sertraline versus placebo for reducing anxiety in adults with a diagnosis of autism.

The active investigational medicinal products are over-encapsulated 25mg or 50mg Sertraline tablets with a back fill of microcrystalline cellulose powder.

All participants will receive a daily oral dose of 25mg sertraline or placebo for 2 weeks followed by 2x25mg for 4 weeks. Following this initiation period, the medication will be dispensed in 50mg capsules and depending upon tolerability, the dose will be flexibly increased by 50mg 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 prescribing clinician is satisfied that it is appropriate to do so based on the participant’s responses to the safety check questionnaire and discussion with the study research staff. The dose may go up to a maximum of 200mg by week 14, although it is anticipated that for many patients the optimal dose may be lower than this amount (e.g. 50mg, 100mg or 150mg) and reached before this time.

Participants will take this optimal dose for up to 52-weeks post-randomisation, which will be the maximum planned time unless there are indications to stop earlier. Participants can choose to withdraw for any reason at any time during their involvement in the trial. Participants can withdraw from: (a) taking study medication, although participants who have taken at least one study medication capsule will be informed that they should take the treatment regimen for at least 16-weeks (i.e. until the primary outcome timepoint) before deciding if the treatment works or not; and (b) providing data to the trial, at any time for any reason without affecting their usual care. The PI can also decide to withdraw participants based on clinical opinion at any time during the trial; a likely scenario might be withdrawing them from taking the study medication. This may be due to safety concerns, severe adverse effects, development of mania or psychosis, or loss of contact such that sending further medication is not deemed safe.

Brief contact (safety checks): 1 to 2-, 4-, 8-, 12-, and 36-weeks post-randomisation
At 1 to 2-, 4-, 8-, 12- and 36-weeks post-randomisation*, the local research (recruitment) team will contact the participant to conduct a brief safety check to assess safety (adverse effects), medication dose titration and adherence (including tablet counting, and return of unused medication), and anxiety and depressive symptoms (including suicidality). This assessment will be carried out via questionnaire and discussion to adequately inform dose titration.

The researcher will convey this assessment to the local PI (“prescriber”, or authorised delegate) for them to review and make the decision regarding further prescription (continue on same dose, increase or decrease). If required, the PI/clinician can arrange to speak with/or arrange to see the participant directly or request further information to enable their decision. The decision to prescribe and amend dosage shall stay with the PI/clinician and not the RA who is responsible for conveying the relevant information to the PI/clinician.

* The initial safety check at 1 to 2 weeks should be at least 1-week, but no later than 2-weeks, post-randomisation. This flexibility is due to potential delay time between being randomised and starting the medication (eg. Picking up or postage delays in medication collection). We anticipate the need for flexibility of +/- 1-week given the pragmatic nature of this trial for the safety checks at 4-, 8-, 12- and 36-weeks post-randomisation.

It is important to note, however, that medication dosage must be discussed with research staff rather than via online questionnaire, only. Where safety is a concern, participants will be encouraged to seek input from their clinician/GP to help with clinical management.

Follow up assessments: 16-, 24- and 52-weeks post-randomisation
Participants will be asked to complete a STRATA Follow Up Questionnaire 16-, 24- and 52- weeks post-randomisation, as well as the assessments completed at the brief safety check timepoints.

Carer Burden Nested Sub Study
A nominated carer of all recruited participants will be invited to participate in a carer sub study, and recruited in parallel to explorer carer burden. It is up to the STRATA participant to define who their carer is; where feasible, it would be one carer who knows them well and is likely to continue caring for them over the 52-week trial period. The carer will be approached only with the agreement of the participant and consented separately. The participant is still able to participate in the trial if carers do not wish to participate, or if there is no carer. Similarly, the carer can continue involvement if the participant withdraws from the main trial. Carers will be asked to complete a STRATA Carer Burden Questionnaire at Baseline, 16- and 52-weeks post-randomisation of the STRATA (main trial) participant.
Intervention code [1] 316319 0
Treatment: Drugs
Comparator / control treatment
The placebo product is an oral capsule filled with microcrystalline cellulose powder, matched to the sertraline product.

The placebo regimen will be identical to the sertraline regime.

Participants will continue to self-administer this optimal dose for up to 52-weeks post-randomisation. Participants can choose to withdraw for any reason at any time during their involvement in the trial. Participants can withdraw from: (a) taking study medication, although participants who have taken at least one study medication capsule will be informed that they should take the treatment regimen for at least 16-weeks (i.e. until the primary outcome timepoint) before deciding if the treatment works or not; and (b) providing data to the trial, at any time for any reason without affecting their usual care.

All follow up assessments and brief safety check time points as mentioned in the 'description of intervention' above are identical for the placebo regime.
Control group
Placebo

Outcomes
Primary outcome [1] 322239 0
To determine the difference in Generalised Anxiety Disorder Assessment (GAD-7) anxiety scores at 16-weeks between adults with a diagnosis of autism treated with sertraline and those treated with placebo.
Instrument used: GAD-7 anxiety score
Timepoint [1] 322239 0
16 weeks post randomisation.
Secondary outcome [1] 377836 0
To describe the adverse effects reported by adults with a diagnosis of autism treated with sertraline versus those treated with placebo over 52-weeks
Instrument used: Modified Toronto side effects scale and open-ended questions (including suicidality item)
Timepoint [1] 377836 0
At baseline, 1 or 2, 4, 8, 12, 16, 24, 36 and 52 weeks post randomisation
Secondary outcome [2] 377837 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on response to anxiety symptoms
Instrument used: any changes in GAD-7 scores
Timepoint [2] 377837 0
At screening, baseline, 1 or 2, 4, 8, 12, 24, 36 and 52 weeks post randomisation
Secondary outcome [3] 391467 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on patient reported effect of medication on symptoms
Instrument used: Study-specific questionnaire
Timepoint [3] 391467 0
At 1 or 2, 4, 8, 12, 16, 24, 36 and 52 weeks post randomisation
Secondary outcome [4] 391469 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on social anxiety
Instrument used: Social Phobia Inventory (SPIN)
Timepoint [4] 391469 0
At baseline, 16, 24 and 52 weeks post randomisation
Secondary outcome [5] 391470 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on obsessive compulsive symptoms
Instrument used: Obsessive Compulsory Inventory Revised (OCI-R)
Timepoint [5] 391470 0
At baseline, 16, 24 and 52 weeks post randomisation
Secondary outcome [6] 391472 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on panic attacks
Instrument used: Brief Patient Health Questionnaire (PHQ) from Primary Care Evaluation of Mental Disorders (PRIME-MD)
Timepoint [6] 391472 0
At baseline, 16, 24 and 52 weeks post randomisation
Secondary outcome [7] 391473 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on repetitive behaviours
Instrument used: Adult Repetitive Behaviours Questionnaire-2 (RBQ-2A)
Timepoint [7] 391473 0
At baseline, 16, 24 and 52 weeks post randomisation
Secondary outcome [8] 391474 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on depressive symptoms
Instrument used: Patient Health Questionnaire-9 (PHQ-9)
Timepoint [8] 391474 0
At baseline, 1 or 2, 4, 8, 12, 16, 24, 36 and 52 weeks post randomisation
Secondary outcome [9] 391475 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on functioning and disability
Instrument used: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Timepoint [9] 391475 0
At baseline, 16, 24 and 52 weeks post randomisation
Secondary outcome [10] 391476 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on quality of life
Instrument used: EuroQol- 5 Dimension 5 Level (EQ-5D-5L) questionnaire
Timepoint [10] 391476 0
At baseline, 12, 16, 24 and 52 weeks post randomisation
Secondary outcome [11] 391477 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on carer burden and quality of life
Instrument used: (composite secondary outcomes) Caregiver Burden Scale, Carer Experience Scale (CES) and EQ-5D-5L questionnaire
Timepoint [11] 391477 0
At baseline, 16 and 52 weeks post randomisation
Secondary outcome [12] 391478 0
To measure adherence to the study medication
Instrument used: study specific questionnaire (adapted from previous trials trials)
Timepoint [12] 391478 0
At 1 or 2, 4, 8, 12, 16, 24, 36 and 52 weeks post randomisation
Secondary outcome [13] 406093 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on meltdowns
Instrument used: Single item ‘had a meltdown’ added to GAD-7 scale
Timepoint [13] 406093 0
At screening, baseline, 1 or 2, 4, 8, 12, 24, 36 and 52 weeks post randomisation
Secondary outcome [14] 406094 0
To determine the effect of up to 52-weeks of treatment with sertraline versus placebo on composite anxiety and depressive symptoms
Instrument used: Sum of PHQ-9 and GAD-7 Scores
Timepoint [14] 406094 0
At baseline, 1 or 2, 4, 8, 12, 24, 36 and 52 weeks post randomisation

Eligibility
Key inclusion criteria
1. Adults aged greater than or equal to 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 greater than or equal to 10 at screening

Carer Burden Nested Sub Study
For the purpose of this carer burden sub-study, it is up to the STRATA (main trial) participant to define who their carer is; where feasible, it would be one carer who knows them well and is likely to continue caring for them over the 52-week trial period. All named carers will be approached and invited to participate in the carer sub study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prescribed a serotonergic antidepressant/anxiolytic at antidepressant doses in preceding 8 weeks- these include SSRI and non-SSRI antidepressants including tricyclic antidepressants. Potential participants who are prescribed low (i.e. non-antidepressant) doses of these medications for other indications (e.g. neuropathic pain); or those who had no such medication for the majority of the preceding 8 weeks (e.g. tried for a few days before stopping) may be considered eligible where the PI confirms this is consistent with usual clinical practice. Individuals prescribed these medications wishing to participate could do so after a washout period of 8 weeks.
2. Prescribed an irreversible monoamine oxidase inhibitor 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. Current valid diagnosis of bipolar disorder, manic or hypomanic episodes, or psychosis. Individuals with historical diagnoses where there is clinical consensus or strong suspicion that these diagnoses are no longer valid (e.g. presentations historically labelled as mania/psychosis now considered to be explained by autism) may be considered eligible based on PI discretion.
6. Currently uncontrolled epilepsy.
7. Known current alcohol or drug use problem (i.e. if recorded in patient/medical notes and the GP/PI considers it unsafe to co-prescribe sertraline).
8. Known allergies to sertraline or placebo/excipients.
9. Currently enrolled in another medication RCT.
10. Women who are pregnant, are planning pregnancy, or breastfeeding.
11. History of 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.

Carer Burden Nested Sub Study
For the purpose of this carer burden sub-study, it is up to the STRATA (main trial) participant to define who their carer is: no exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The local Principal Investigator (PI) (or authorised delegate) will sign into the secure online randomisation system (Sealed Envelope [Trademark]), enter the individual’s (patient’s) unique study I.D number and necessary minimisation variables; they will then receive the code that allocates the participant to the study treatment, and this code should be recorded on the study-specific prescription. The recruiter(s) and the participant will remain blinded as to which treatment group this code refers to. The trial pharmacies in the UK and Australia will be directly informed of the randomisation code for UK and Australia-based patients, respectively. The unblinded randomisation code will be held by the study pharmacies and selected members of the Bristol Randomised Trials Collaboration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by Sealed Envelope [Trademark]. Randomisation will be stratified by centre, with minimisation to ensure balance in baseline GAD-7 score (less than 15 and greater than or equal to 15), gender (male, female, non-binary), age (18-34, 35-49 and greater than or equal to 50), presence of intellectual disability (yes/no), and previous medication use for anxiety or depression (yes/no). Patients will be randomised to one of two treatment groups on a 1:1 ratio, that is either sertraline (intervention arm) or placebo (control arm).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The target sample size in Australia is 75. The total over all sites (Australia and UK combined) is 306 participants. The planned analysis will be completed on the entire sample of 306 participants as stated below.

Sample size calculation
Main trial
The sample size calculations are based on the literature regarding the primary outcome (GAD-7) and experience in the NIHR-funded ADEPT study in adults with autism. A reduction of 2 to 3 points on the total GAD-7 score has been reported as a clinically important change and based on this this trial is designed to detect a difference of 2.2 points on the GAD-7 between treatment arms at 16-weeks. The results from the Autism Depression Trial (ADEPT) study suggest a standard deviation (SD) in GAD-7 scores of 5.7 meaning the target difference equates to approximately 0.39 SD. Based on this, the study aims to recruit 306 participants, which, estimating 20% attrition at 16-weeks and a correlation of 0.37 between the baseline and 12-week GAD-7 scores will yield 90% power (alpha=0.05) to estimate a mean difference of 2.2 points in GAD-7 scores between groups as randomised. By randomising 306 patients the study will have at least 80% power to detect the following differences in GAD-7 scores between treatment arms:

Difference in GAD-7 scores between treatment arms at 16-weeks
2.5 2.4 2.3 2.2 2.1 2.0 1.9
Power 95.8% 94.3% 92.4% 90.1% 87.2% 83.9% 80%

Carer burden sub-study
No a priori sample size calculation was conducted for the sub-study of carers. This study will include all eligible and consenting carers of randomised STRATA participants. Should all 306 STRATA participants have a recruited carer participating in the study, the study will have 90% power (alpha-0.05) to detect a 0.4SD difference in the carer burden scale assuming 30% attrition. Should half of STRATA participants have a recruited carer participating in the study, the study will have 90% power (alpha=0.5) to detect a 0.6SD difference, assuming 30% attrition.

Statistical analysis
All analyses and reporting will be in line with Consolidated Standards of Reporting Trials (CONSORT) guidelines. Primary analyses will be based on the intention-to-treat (ITT) basis, analysing participants in the groups to which they were randomised. A full Statistical Analysis Plan (SAP) will be developed by the Statisticians and central research team, and agreed by the Trial Steering Committee (TSC) prior to undertaking analyses for the main trial.

Summary of baseline data
Descriptive statistics will be used to determine whether there are imbalances at baseline between treatment groups therefore informing any sensitivity analyses to be performed where appropriate additional adjustment will be performed. Continuous measures will be presented as means and SDs or medians, inter-quartile ranges, and ranges depending on their distribution. Categorical data will be presented as frequencies and proportions.
Baseline variables to be explored. Patient reported outcome scores based on standardised questionnaires will be calculated based on the developers’ scoring manuals and missing erroneous items will be handled according to these manuals.

Primary outcome analysis
The primary analysis of effectiveness of the primary outcome will use linear regression to estimate an adjusted mean difference comparing GAD-7 score at 16-weeks post-randomisation between groups, adjusted for baseline values of the outcome, centre, sex, presence of intellectual disability and previous use of Selective Serotonin Reuptake Inhibitor(s) (SSRIs) (stratification/minimization variables).

Secondary analyses of the primary outcome will include a Complier Average Causal Effect (CACE) analysis to investigate the efficacy of the intervention (based on treatment compliance status) for comparison with the ITT estimate of the offer of the intervention and a per protocol analysis which will account for those patients taking treatments other than that which they were allocated to. These will be conducted at 16- and 52-weeks.

Secondary outcome analysis
The effect of the intervention on the secondary outcomes collected at 16-, 24-, 36- and 52-weeks post-randomisation will also be examined using linear regression for continuous outcomes and logistic regression for binary outcomes adjusted for baseline values of the outcome being investigated and stratification/minimization variables.
As it is possible that adherence to treatments will decrease over the 52-week follow-up, we will describe this at each timepoint by arm as well as the use of additional or alternative medications or other treatments. A repeated measures analysis using GAD-7 outcome data collected at multiple follow up timepoints will be carried out to examine the effect of the intervention over 52-weeks.

Subgroup analysis
A number of pre-defined subgroup analyses will be carried out to assess the difference in treatment effect on the primary outcome according characteristics assessed at baseline. Characteristics of interest include whether the diagnosis of autism was made as an adult or child, the presence of mild intellectual disorders, duration of specialist care and severity of anxiety symptoms. Effect modification will be assessed by including an interaction term in the regression model and formal tests of interaction will be performed to test whether the treatment effect differs between these groups. As the study was not powered to detect such effects results will be interpreted with caution.

Adjusted analysis
All analyses will adjust for baseline values of the outcome, stratification and minimisation variables. Secondary analyses of the primary outcome will adjust for any prognostic variables showing a marked imbalance at baseline (ascertained using descriptive statistics).

Carer burden sub-study
Descriptive statistics will be used to describe the baseline characteristics of carers participating in the carer burden sub-study as well as the randomised participants they are caring for. These results will be used to determine whether there are imbalances at baseline between treatment groups and suggest whether appropriate additional adjustment should be performed. Continuous measures will be presented as means and SDs or medians, inter-quartile ranges, and ranges depending on their distribution. Categorical data will be presented as frequencies and proportions.
Scores based on standardised questionnaires will be calculated based on the developers’ scoring manuals and missing erroneous items will be handled according to these manuals. The carers’ EQ-5D-5L health states will be valued using the method recommended by National Institute for Health and Care Excellence (NICE) at the time of analysis; the current position statement recommends the use of the Van Hout crosswalk.
The effect of the intervention on the carer burden scale, carers experience scale and EQ-5D-5L collected at 16- and 52-weeks post-randomisation will be examined using linear regression adjusting for baseline values, variables used in the randomisation and any variables found to be imbalanced at baseline.

Analysis of safety endpoints
Descriptive analyses of safety endpoints will be presented at each timepoint according to treatment received. No formal comparisons will be made between groups.

Missing data
The sensitivity of the primary analysis to the impact of missing data will be investigated. The data will first be explored before a decision is made on what approach to utilise. These include exploring the amount of missingness, differences between arms, variables associated with/predictive of missingness and if reported, reasons for missingness. The approach taken to handling missing data will then depend on the assumptions about the nature of the missingness deemed to be appropriate. For example, if an assumption of Missing At Random is deemed appropriate then multiple imputation will be carried out and the primary analysis repeated using the imputed data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/02/2022
Actual
9/02/2022
Date of last participant enrolment
Anticipated
30/11/2024
Actual
26/10/2023
Date of last data collection
Anticipated
28/11/2024
Actual
Sample size
Target
75
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15445 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 28795 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 304501 0
Government body
Name [1] 304501 0
National Health and Medical Research Council (NHMRC)
Country [1] 304501 0
Australia
Funding source category [2] 304503 0
Government body
Name [2] 304503 0
National Institute for Health Research (NIHR)
Country [2] 304503 0
United Kingdom
Primary sponsor type
University
Name
The University of Western Australia (UWA)
Address
The University of Western Australia
35 Stirling Hwy
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 304769 0
University
Name [1] 304769 0
University of Bristol (UoB)
Address [1] 304769 0
University of Bristol
Senate House
Tyndall Ave
Tyndalls Park
Bristol, BS8 1TH
UK
Country [1] 304769 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304934 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 304934 0
Level 2, Education Building
Fiona Stanley Hospital Campus
Locked Bag 100, Palmyra DC,
Western Australia, 6961
Ethics committee country [1] 304934 0
Australia
Date submitted for ethics approval [1] 304934 0
21/01/2021
Approval date [1] 304934 0
25/03/2021
Ethics approval number [1] 304934 0
RGS0000003578
Ethics committee name [2] 307854 0
Oxford B REC
Ethics committee address [2] 307854 0
Health Research Authority
Temple Quay House,
2 The Square, Temple Quay
Bristol BS1 6PN
UK
Ethics committee country [2] 307854 0
United Kingdom
Date submitted for ethics approval [2] 307854 0
11/01/2021
Approval date [2] 307854 0
02/02/2021
Ethics approval number [2] 307854 0
22/SC/0296

Summary
Brief summary
Anxiety is common in autistic adults and can be more disabling than the core features of autism. Medications for anxiety are often prescribed for autistic adults but their effectiveness or side effects in this population are not well known. Research findings in non-autistic populations may not apply to autistic adults.
This study aims to find out whether the drug sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. We will compare the use of sertraline in autistic adults with placebo, a non-active identical capsule. We are interested to see whether the treatment improves symptoms of anxiety, enhances quality of life, and is effective in the longer term. We are also interested in understanding side effects of the treatment.
We will run this trial in five geographical regions in England and Western Australia. We aim to include 75 people in Australia (total study population will be 306 internationally) who will be allocated at random to receive either encapsulated sertraline or identical inactive placebo, which they will be asked to take for up to 12 months.
They will be asked to complete questionnaires about themselves, their anxiety and mental health, use of services, and any adverse effects they may experience at several time points. The results will help understand whether sertraline is an acceptable treatment and whether it is better or not than placebo in the treatment of anxiety in autistic adults.
Trial website
www.bristol.ac.uk/strata
Trial related presentations / publications
Public notes
Please also note the UK team of this study is also trying to determine the cost effectiveness of sertraline treatment for anxiety in adults with a diagnosis of autism, and well as exploring participants’ acceptability, experiences of, and adherence to, study processes and treatment, This is done by performing qualitative recorded video interviews after the trial is completed.

Contacts
Principal investigator
Name 98682 0
A/Prof Helen Leonard
Address 98682 0
The University Of Western Australia
35 Stirling Hwy, Crawley, WA, 6009
Country 98682 0
Australia
Phone 98682 0
+61 419956946
Fax 98682 0
Email 98682 0
Helen.Leonard@uwa.edu.au
Contact person for public queries
Name 98683 0
A/Prof Helen Leonard
Address 98683 0
The University Of Western Australia
35 Stirling Hwy, Crawley, WA, 6009
Country 98683 0
Australia
Phone 98683 0
+61 419956946
Fax 98683 0
Email 98683 0
Helen.Leonard@uwa.edu.au
Contact person for scientific queries
Name 98684 0
A/Prof Helen Leonard
Address 98684 0
The University Of Western Australia
35 Stirling Hwy, Crawley, WA, 6009
Country 98684 0
Australia
Phone 98684 0
+61 419956946
Fax 98684 0
Email 98684 0
Helen.Leonard@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
If you take part in this study, de-identified data collected in this study may be used in future ethically approved studies; this will never include names, dates of birth, or contact details, and it will not be possible to identify individual participants.
When will data be available (start and end dates)?
It is anticipated that the anonymised data will be available upon request, immediately following publication, with no end date determined.
Available to whom?
Data will be made available to approved bona fide researchers only, after their host institution has signed a data access agreement. This is on a case by case basis at the discretion of the research team.
Available for what types of analyses?
We anticipate that anonymised trial data will be kept for future analysis and may be shared with other researchers to enable international prospective meta-analyses.
How or where can data be obtained?
The final trial data set will be stored as restricted data on the data.bris research data repository. Details of how to request access are available at the University of Bristol’s data repository website (https://data.bris.ac.uk/data/) or they can be emailed at data-bris@bristol.ac.uk


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10630Informed consent form  strata@uwa.edu.au Participant and Carer Consent Forms
10895Other  strata@uwa.edu.au Participant and Carer Participant Information Leaf... [More Details]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.2024https://dx.doi.org/10.1186/s13063-023-07847-3
N.B. These documents automatically identified may not have been verified by the study sponsor.