Clinical Trial: A Trial of Sertraline in Young Children With Autism Spectrum Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder

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 Summary:

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.

Current Primary Outcome: Change from baseline in Mullen Scales of Early Learning (MSEL) at six months [ Time Frame: Baseline and six months ]

Original Primary Outcome: Change from baseline in Clinical Global Impression Scale at three months and six months [ Time Frame: Baseline, three months, and six months ]

Current Secondary Outcome:

• Vineland Adaptive Behavior Scales-II [ Time Frame: Baseline and six months ]
  parent interview assessing communication, daily living skills, socialization, and motor skills.
• Preschool Anxiety Scale-Revised [ Time Frame: Baseline and six months ]
  parent report of generalized anxiety, social anxiety, separation anxiety, and specific fears
• Preschool Language Scale- Fifth Edition [ Time Frame: Baseline and six months ]
  The Preschool Language scale assesses auditory comprehension and expressive communication for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The assessment has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The assessment also has a means by which to track progress using Growth Scores to monitor a child's skills.
• Sensory Processing Measure [ Time Frame: Baseline and six months ]
  designed to measure sensory processing difficulties in multiple environments (at home, at school, and in the community) for children.
• Change from baseline in Clinical Global Impression Scale at three months and six months [ Time Frame: Baseline, three months, and six months ]
  The physician assesses improvement or worsening of symptoms on a scale of very much improved, much improved, minimal improvement, no improvement, minimally worse, and very much worse.

Original Secondary Outcome:

• Vineland Adaptive Behavior Scales-II [ Time Frame: Baseline and six months ]
  parent interview assessing communication, daily living skills, socialization, and motor skills
• Preschool Anxiety Scale-Revised [ Time Frame: Baseline and six months ]
  parent report of generalized anxiety, social anxiety, separation anxiety, and specific fears
• Preschool Language Scale- Fifth Edition [ Time Frame: Baseline and six months ]
  The Preschool Language scale assesses auditory comprehension and expressive communication for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The assessment has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The assessment also has a means by which to track progress using Growth Scores to monitor a child's skills.
• Sensory Processing Measure [ Time Frame: Baseline and six months ]
  designed to measure sensory processing difficulties in multiple environments (at home, at school, and in the community) for children
• Repetitive Behavior Scale- Revised [ Time Frame: Baseline and six months ]
  44-item parent report used to measure the breadth of repetitive behaviors in children with Autism spectrum disorders. It consists of six subscales including: stereotyped behavior, self-injurious behavior, compulsive behavior, routine behavior, sameness behavior. and restricted behavior. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem.
• Autism Diagnostic Observation Scale [ Time Frame: Baseline and six months ]
  The Autism Diagnostic Observation Scale uses developmentally appropriate social and object-based interactions in a 30-45 minute interview to elicit symptoms of autism in four areas: social interaction, communication, play, and repetitive, restrictive behaviors. The assessment consists of different modules, each directed at a particular level of language ability and is thus appropriate to use across subjects of varying ages and functioning levels.
• Mullen Scales of Early Learning [ Time Frame: Baseline and six months ]
  cognitive assessment measuring gross motor, fine motor, visual reception, expressive language and receptive language in children from birth to 68 months of age.

Dates:
Date Received: February 9, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: October 24, 2016
Last Verified: October 2016