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NCT03279471 · ClinicalTrials.gov registry record · Phase 2

Specifying and Treating Anxiety in Autism Research

A Phase 2 study of Anxiety and Autism Spectrum Disorder, sponsored by University of California, Davis.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target
1
Study location

NCT03279471 is a Phase 2 study of Anxiety and Autism Spectrum Disorder that has completed, run by University of California, Davis. The registered enrollment target is 68 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03279471, a Phase 2 study of Anxiety and Autism Spectrum Disorder, has completed, sponsored by University of California, Davis.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target
1
Study location

Study Summary

The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI visits. The study provides 16-weeks of anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study completion a 3 month follow up call is conducted and participants in the placebo group are given the option to participate in an additional study phase with the study treatment of their choice. Study participation can be done remotely through the use of telehealth and local labs, visits to the UC Davis MIND Institute are not required for most participants.

Interventions

  • DRUG Placebo
  • DRUG Sertraline
  • BEHAVIORAL CBT/BIACA

Study Locations (1)

California

  • UC Davis MIND Institute - Sacramento

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2017-10-01
Est. Completion 2023-02-22
Phase Phase 2

Sponsor

University of California, Davis

657 total trials

What the Registry Record Tells You About NCT03279471

The ClinicalTrials.gov registry entry for NCT03279471 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (85% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03279471 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03279471 about?

NCT03279471 is a clinical study titled "Specifying and Treating Anxiety in Autism Research". The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-week randomized comparative treatment trial of the Behavioral I...

What is the current status of trial NCT03279471?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2017-10-01. Estimated completion is 2023-02-22.

What conditions does trial NCT03279471 study?

This clinical trial studies the following conditions: Anxiety, Autism Spectrum Disorder.

What interventions are being tested in trial NCT03279471?

The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG), CBT/BIACA (BEHAVIORAL).

Who is sponsoring clinical trial NCT03279471?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03279471 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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