Sertraline + Cognitive Behavioural Therapy for Anxiety in Autism

(STAAR Trial)

Overseen By Erika Bickel, CCRP

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must not be taking: SSRIs

Disqualifiers: Bipolar, Schizophrenia, Suicidal behaviors, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to treat anxiety in children and preadolescents with autism. Researchers are testing a behavioral therapy called BIACA, the medication sertraline, and a placebo to determine which is most effective. Children aged 8-14 with autism who experience noticeable anxiety as their main mental health challenge are ideal candidates. The study can be conducted mostly from home using telehealth, eliminating the need to travel to the UC Davis MIND Institute unless chosen otherwise. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that participants have a stable medication regimen for 8 weeks before starting, so you likely won't need to stop your current medications if they have been stable. However, if you are receiving significant psychosocial treatment for anxiety, you may need to stop those services to join the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that children with autism who received Behavioral Interventions for Anxiety in Children with Autism (BIACA) therapy had lower anxiety levels compared to those who did not. This finding suggests that BIACA is safe and effective for reducing anxiety in children with autism.

Sertraline, an SSRI medication, is often used to treat anxiety and depression. Research has shown that short-term use of sertraline in children with autism is safe. However, while it is approved for treating conditions like obsessive-compulsive disorder (OCD) in children, its safety for treating anxiety in children with autism remains under investigation.

In this trial, both treatments have some safety data available, but more research is needed to understand their long-term effects. Researchers will closely monitor participants to ensure the treatments are safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments under study for anxiety in children with autism because they offer unique approaches compared to standard options like traditional Cognitive Behavioral Therapy (CBT) and medications such as sertraline. The BIACA method combines CBT with social skills training specifically tailored for children with Autism Spectrum Disorder (ASD), potentially offering a more comprehensive way to address anxiety by targeting both anxiety reduction and social interaction improvements. Additionally, while sertraline is a known treatment for anxiety, this trial explores its effectiveness specifically in the context of ASD, which could lead to more targeted use in this population. This combination of tailored therapy and refined medication use could lead to more effective and personalized anxiety management for children with ASD.

What evidence suggests that this trial's treatments could be effective for anxiety in children with autism?

Research has shown that cognitive behavioral therapy (CBT), such as the BIACA program, effectively reduces anxiety in children with Autism Spectrum Disorder (ASD). Studies indicate that specially adapted CBT for children with ASD leads to much lower anxiety levels compared to standard methods. In this trial, some participants will receive the BIACA program, while others will receive sertraline, a medication commonly used to treat anxiety. However, studies have shown that sertraline does not significantly reduce anxiety symptoms in young children with ASD. Multiple studies have demonstrated no improvement with sertraline on main or additional anxiety measures in this group. Overall, BIACA appears promising for managing anxiety in kids with ASD. ^{1 2 3 6 7}

Who Is on the Research Team?

Marjorie Solomon, PH.D.

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

Inclusion Criteria

Outpatient boys and girls with ASD between ages 8-14 years at consent

Stable non-psychotherapy regimen for 4 weeks prior to screening visits. Non-psychotherapy regimen may include: Academic tutoring, Occupational therapy, Speech therapy, School aides

Stable medication regimen for 8 weeks prior to screening visit, including alternative medication, nutritionals, or therapeutic diets

Exclusion Criteria

Abnormal laboratory or electrocardiogram results at screening that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject

Child has a major neurological disorder or medical illness that requires a prohibited episodic or chronic systemic medication that might interfere with the absorption, distribution, metabolism, or excretion of the study medication places the subject at increased risk, or that would interfere with study participation (e.g., frequent hospitalizations, frequent school absences)

Child pregnancy as indicated by history or positive pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

2-3 half day telehealth visits for behavioral and medical assessments

Treatment

Participants receive 16 weeks of anxiety treatment involving weekly BIACA therapy or medical check-up visits

16 weeks

Weekly visits (in-person or telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 follow-up call

Optional Extension

Participants in the placebo group are given the option to participate in an additional study phase with the study treatment of their choice

What Are the Treatments Tested in This Trial?

Interventions

• BIACA
• Placebo
• Sertraline

How Is the Trial Designed?

Group I: CBT/BIACA Experimental Treatment 1 Intervention

These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training.

Group II: Sertraline Active Control 1 Intervention

These participants will receive sertraline

Group III: Pill Placebo Placebo Group 1 Intervention

These individuals will receive a pill placebo.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

In a combined analysis of two multicenter clinical trials, sertraline significantly reduced the mean number of panic attacks per week in patients with panic disorder compared to placebo (4.8 vs. 2.5, p < .001).

Patients treated with sertraline also showed statistically significant improvements in various symptoms and functioning related to panic disorder, highlighting its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodologies and outcomes from the sertraline multicenter flexible-dose trials. Rapaport, MH., Wolkow, RM., Clary, CM.[2013]

In a study involving 1251 patients, sertraline was found to have a similar safety profile to other SSRIs, with common side effects like nausea, headache, and diarrhea reported by both groups.

Despite the similarities, sertraline users reported a higher incidence of diarrhea compared to users of other SSRIs, and the study identified over 100 different unlabelled adverse events, indicating the need for ongoing monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. Meijer, WE., Heerdink, ER., van Eijk, JT., et al.[2022]

In a study of 178 out-patients with panic disorder, sertraline significantly reduced the frequency of panic attacks and anxiety symptoms compared to placebo over 12 weeks, demonstrating its efficacy in treating panic disorder.

Sertraline was found to be safe, with no serious adverse events reported, although some patients experienced mild side effects like dry mouth and ejaculation issues, and higher doses did not provide additional benefits over the 50 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. Londborg, PD., Wolkow, R., Smith, WT., et al.[2022]

Coadministration of sertraline with cisapride significantly reduced cisapride plasma concentrations (by 29% for Cmax and 36% for AUC), but did not affect QTc intervals, indicating a safe interaction.

In contrast, sertraline increased pimozide plasma concentrations (by 35% for Cmax and 37% for AUC) without prolonging QTc intervals, suggesting that the interaction mechanisms may involve factors beyond the CYP3A4 enzyme.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coadministration of sertraline with cisapride or pimozide: an open-label, nonrandomized examination of pharmacokinetics and corrected QT intervals in healthy adult volunteers. Alderman, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31755906/

Cognitive Behavioral Treatments for Anxiety in Children With ... In this study, CBT was efficacious for children with ASD and interfering anxiety, and an adapted CBT approach showed additional advantages.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6902190/

Cognitive Behavioral Treatments for Anxiety in Children ... Cognitive behavioral therapy designed for children with ASD yielded significantly lower anxiety scores on the primary outcome measure than standard-of-practice ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01178385

Cognitive-Behavioral Treatment for Anxiety Disorders in ... Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946718300746

Cognitive behavior therapy to treat anxiety among children ... The results of this review offer empirically support for modified CBT for children with autism as an EST. Findings also indicate that little research has ...

5. molecularautism.biomedcentral.com molecularautism.biomedcentral.com/articles/10.1186/s13229-020-00341-6

Effectiveness of a modified group cognitive behavioral therapy ... Overall, this study demonstrated that community implementation of a modified group CBT program for youth with ASD is feasible and effective for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5523838/

The Treatment of Anxiety in Autism Spectrum Disorder ... The Behavioral Interventions for Anxiety in Children with Autism (BIACA) program is an individual, modular CBT program for children with ASD. In an exploratory ...

7. yalemedicine.org yalemedicine.org/clinical-trials/cbt-for-anxiety-in-children-with-autism

CBT for Anxiety in Children With Autism This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus Psychoeducation and Supportive Therapy (PST) in children with Autism ...