A Trial of Sertraline in Young Children With Autism Spectrum Disorder

NCT ID: NCT02385799

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-07-31

Brief Summary

This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.

Detailed Description

This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder (ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a retrospective study has shown significant improvements in language and social deficits. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.

The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with ASD who are between the ages of 2 years and 5 years old inclusive. At baseline, the researchers will assess behavioral and cognitive development. Each participant will be involved in this trial for a period of six months. This will include three visits to the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side effects of the sertraline treatment throughout the study.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sertraline Liquid Placebo

The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4 years to 6 years will be given 5 mg of liquid placebo once per day for a period of six months.

Group Type: PLACEBO_COMPARATOR

Sertraline Liquid Placebo

Intervention Type: DRUG

Liquid placebo given in parallel to active medication

Sertraline Active Medication

Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4 years to 6 years will be given 5 mg of liquid sertraline once per day for a period of six months.

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

Active medication

Interventions

Sertraline Liquid Placebo

Liquid placebo given in parallel to active medication

Intervention Type: DRUG

Sertraline

Active medication

Intervention Type: DRUG

Other Intervention Names

Placebo; Zoloft

Eligibility Criteria

Inclusion Criteria

• Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
• Subject between the ages of 24-72 months of age.
• A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
• Stable medications during the two months prior to enrollment.
• Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria

• Current or past Selective Serotonin Reuptake Inhibitor treatment.
• Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Randi J. Hagerman, MD

OTHER

Sponsor Role: lead

Responsible Party

Randi J. Hagerman, MD

UC Davis MIND Institute Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Randi J Hagerman, M.D.

Role: PRINCIPAL_INVESTIGATOR

UC Davis MIND Institute

Locations

UC Davis MIND Institute

Sacramento, California, United States

Countries

United States

References

Potter LA, Scholze DA, Biag HMB, Schneider A, Chen Y, Nguyen DV, Rajaratnam A, Rivera SM, Dwyer PS, Tassone F, Al Olaby RR, Choudhary NS, Salcedo-Arellano MJ, Hagerman RJ. A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder. Front Psychiatry. 2019 Nov 6;10:810. doi: 10.3389/fpsyt.2019.00810. eCollection 2019.

Reference Type: DERIVED

PMID: 31780970 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

663866

Identifier Type: -

Identifier Source: org_study_id