Phase 2
Completed N=58
A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov NCT02385799 ↗Enrolled (actual)
58
Serious AEs
1.7%
Results posted
May 2019
Primary outcomePrimary: Change in Mullen Scales of Early Learning - Expressive Language Raw Score — 19.69; 18.19; 21.81; 20.31 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mullen Scales of Early Learning - Expressive Language Raw Score |
19.69; 18.19; 21.81; 20.31 | — |
| PRIMARY Change in Mullen Scales of Early Learning - Combined Age Equivalent Score |
25.61; 24.98; 30.30; 28.16 | — |
| SECONDARY Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score |
71.52; 69.68 | — |
| SECONDARY Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score |
71.52; 69.68 | — |
| SECONDARY Preschool Anxiety Scale-Revised - Total Score |
11.43; 14.77 | — |
| SECONDARY Preschool Anxiety Scale-Revised - Total Score |
11.43; 14.77 | — |
| SECONDARY Preschool Language Scale-Fifth Edition - Total Language Raw Score |
57.24; 51.40 | — |
| SECONDARY Preschool Language Scale-Fifth Edition - Total Language Raw Score |
57.24; 51.40 | — |
| SECONDARY Sensory Processing Measure-Preschool - Social Participation Raw Score |
20.86; 21.16 | — |
| SECONDARY Sensory Processing Measure-Preschool - Social Participation Raw Score |
20.86; 21.16 | — |
| SECONDARY Clinical Global Impression Scale-Severity (CGI-S) |
4.38; 4.66 | — |
| SECONDARY Clinical Global Impression Scale-Improvement (CGI-I) |
1.14; 1.23 | — |
| SECONDARY Clinical Global Impression Scale-Improvement (CGI-I) |
1.14; 1.23 | — |
| SECONDARY Visual Analog Scale - Language/Communication Score |
5.53; 4.70 | — |
| SECONDARY Visual Analog Scale - Language/Communication Score |
5.53; 4.70 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02385799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.