Clinical trial NCT02385799: A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Official title: A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Behavior
sertraline
treatment
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2015-03-11
Enrollment: 58
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Mullen Scales of Early Learning - Expressive Language Raw Score
timeFrame: From baseline visit to six-month visit
measure: Change in Mullen Scales of Early Learning - Combined Age Equivalent Score
timeFrame: From baseline visit to six-month visit
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
timeFrame: At baseline visit
measure: Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
timeFrame: At six-month visit
measure: Preschool Anxiety Scale-Revised - Total Score
timeFrame: At baseline visit
measure: Preschool Anxiety Scale-Revised - Total Score
timeFrame: At six-month visit
measure: Preschool Language Scale-Fifth Edition - Total Language Raw Score
timeFrame: At baseline visit
measure: Preschool Language Scale-Fifth Edition - Total Language Raw Score
timeFrame: At six-month visit
measure: Sensory Processing Measure-Preschool - Social Participation Raw Score
timeFrame: At baseline visit
measure: Sensory Processing Measure-Preschool - Social Participation Raw Score
timeFrame: At six-month visit
measure: Clinical Global Impression Scale-Severity (CGI-S)
timeFrame: At baseline visit
measure: Clinical Global Impression Scale-Improvement (CGI-I)
timeFrame: At three-month visit
measure: Clinical Global Impression Scale-Improvement (CGI-I)
timeFrame: At six-month visit
measure: Visual Analog Scale - Language/Communication Score
timeFrame: At baseline visit
measure: Visual Analog Scale - Language/Communication Score
timeFrame: At six-month visit
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Randi J Hagerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.