Specifying and Treating Anxiety in Autism Research

(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

68 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two treatments for anxiety in children with autism: a special type of therapy and a medication called sertraline. It focuses on kids aged 8-14 who have significant anxiety. The therapy teaches coping skills, while the medication helps balance brain chemicals to reduce anxiety.

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.

What data supports the effectiveness of the drug sertraline?

Research shows that sertraline is effective in treating major depression, with patients experiencing significant improvement compared to those taking a placebo. It also helps reduce panic attacks in patients with panic disorder. ^{1 2 3 4 5}

Is sertraline generally safe for humans?

Sertraline has been studied for safety in various conditions like depression, panic disorder, and others, showing a generally safe profile in humans. However, it may interact with certain medications, so it's important to consult a healthcare provider. ^{2 4 6 7 8}

Research Team

Marjorie Solomon, PH.D.

Principal Investigator

UC Davis

Eligibility Criteria

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

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

Treatment Details

Interventions

• BIACA
• Placebo
• Sertraline

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A double-blind placebo-controlled multicentre study of sertraline in the acute and continuation treatment of major depression. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Sertraline in Patients With Major Depressive Disorder Naive to Selective Serotonin Reuptake Inhibitors: A 10-Week Randomized, Multicenter, Placebo-Controlled, Double-Blind, Academic Clinical Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

From the Bench to the Trench: A Comparison of Sertraline Treatment of Major Depression in Clinical and Research Patient Samples. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Methodologies and outcomes from the sertraline multicenter flexible-dose trials. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation. [2022]

8. United States 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. [2022]