A Trial of Sertraline in Young Children With Autism Spectrum Disorder

NCT02385799 | Completed Phase 2 Results DMC

• 1 other identifier: 663866
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Behavior; sertraline; treatment

Outcome Measures

Primary Outcomes (2)

• Change in Mullen Scales of Early Learning - Expressive Language Raw Score

  The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.

  From baseline visit to six-month visit

• Change in Mullen Scales of Early Learning - Combined Age Equivalent Score

  The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up combined age equivalent scores, calculated as the sum of the age equivalent scores from each scale. The combined score ranges from 0 to 280. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.

  From baseline visit to six-month visit

Secondary Outcomes (13)

• Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score

  At baseline visit

• Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score

  At six-month visit

• Preschool Anxiety Scale-Revised - Total Score

  At baseline visit

• Preschool Anxiety Scale-Revised - Total Score

  At six-month visit

• Preschool Language Scale-Fifth Edition - Total Language Raw Score

  At baseline visit

Study Arms (2)

Sertraline Liquid Placebo

PLACEBO COMPARATOR

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.

Drug: Sertraline Liquid Placebo

Sertraline Active Medication

ACTIVE COMPARATOR

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.

Drug: Sertraline

Interventions

Sertraline Liquid Placebo DRUG

Liquid placebo given in parallel to active medication

Also known as: Placebo

Sertraline Liquid Placebo

Sertraline DRUG

Active medication

Also known as: Zoloft

Sertraline Active Medication

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Randi J. Hagerman, MD: lead
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 31780970 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Behavior

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Not having minimum or maximum verbal or other developmental requirements to qualify for inclusion in this study. Sample size is small due to significant recruitment/retention challenges. Study power threshold was not met.

Results Point of Contact

• Title: Dr. Randi Hagerman
• Organization: UC Davis MIND Institute

rjhagerman@ucdavis.edu

916-703-0247

Study Officials

• Randi J Hagerman, M.D.

  UC Davis MIND Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: UC Davis MIND Institute Medical Director

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: March 11, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 22, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)