Trial · NCT02385799

A Trial of Sertraline in Young Children With Autism Spectrum Disorder

NCT02385799, Phase 2, Completed, Randi J. Hagerman, MD; results first posted 2019-05-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Trial of Sertraline in Young Children With Autism Spectrum Disorder. Trials, record NCT02385799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02385799

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of Sertraline in Young Children With Autism Spectrum Disorder
NCT number: NCT02385799
Status: Completed
Phases: Phase 2
Enrollment: 58 participants, actual
Lead sponsor: Randi J. Hagerman, MD
Conditions: Autism Spectrum Disorder
Interventions: Sertraline Liquid Placebo, Sertraline
First posted: 2015-03-11
Last updated: 2019-10-22
Results first posted: 2019-05-09
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.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Mullen Scales of Early Learning - Expressive Language Raw Score	From baseline visit to six-month visit	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.
Primary	Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	From baseline visit to six-month visit	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.
Secondary	Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	At baseline visit	The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
Secondary	Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	At six-month visit	The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the six-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
Secondary	Preschool Anxiety Scale-Revised - Total Score	At baseline visit	Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at baseline.
Secondary	Preschool Anxiety Scale-Revised - Total Score	At six-month visit	Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at the six-month visit.
Secondary	Preschool Language Scale-Fifth Edition - Total Language Raw Score	At baseline visit	The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from 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 PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.
Secondary	Preschool Language Scale-Fifth Edition - Total Language Raw Score	At six-month visit	The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from 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 PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the six-month visit.
Secondary	Sensory Processing Measure-Preschool - Social Participation Raw Score	At baseline visit	The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at baseline, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.
Secondary	Sensory Processing Measure-Preschool - Social Participation Raw Score	At six-month visit	The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at the six-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Mullen Scales of Early Learning - Expressive Language Raw Score	From baseline visit to six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.	score on a scale	MEAN
PRIMARY	Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	From baseline visit to six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.	score on a scale	MEAN
SECONDARY	Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	At baseline visit		score on a scale	MEAN
SECONDARY	Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	At six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.	score on a scale	MEAN
SECONDARY	Preschool Anxiety Scale-Revised - Total Score	At baseline visit	Placebo group: staff inadvertently neglected to administer this questionnaire to the 2 subjects' caregivers at baseline, so only 24 were completed.	score on a scale	MEAN
SECONDARY	Preschool Anxiety Scale-Revised - Total Score	At six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.	score on a scale	MEAN
SECONDARY	Preschool Language Scale-Fifth Edition - Total Language Raw Score	At baseline visit	Sertraline group: 2 subjects were completely nonverbal at baseline, so the rater determined that their assessments could not be completed; therefore, only 30 subjects in this arm were analyzed at baseline.	score on a scale	MEAN
SECONDARY	Preschool Language Scale-Fifth Edition - Total Language Raw Score	At six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.	score on a scale	MEAN
SECONDARY	Sensory Processing Measure-Preschool - Social Participation Raw Score	At baseline visit	Placebo group: staff inadvertently neglected to administer this questionnaire to 1 subject's caregiver at baseline, so only 25 were completed. Sertraline group: staff inadvertently neglected to administer this questionnaire to 1 subject's caregiver at baseline, so only 31 were completed.	score on a scale	MEAN
SECONDARY	Sensory Processing Measure-Preschool - Social Participation Raw Score	At six-month visit	Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.	score on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Sertraline Liquid Placebo	Baseline	19.69	Standard Deviation 11.69	score on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Sertraline Active Medication	Baseline	18.19	Standard Deviation 10.39	score on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Sertraline Liquid Placebo	Follow-up	21.81	Standard Deviation 14.29	score on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Sertraline Active Medication	Follow-up	20.31	Standard Deviation 11.70	score on a scale
Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	Sertraline Liquid Placebo	Baseline	25.61	Standard Deviation 11.73	score on a scale
Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	Sertraline Active Medication	Baseline	24.98	Standard Deviation 12.79	score on a scale
Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	Sertraline Liquid Placebo	Follow-up	30.30	Standard Deviation 15.58	score on a scale
Change in Mullen Scales of Early Learning - Combined Age Equivalent Score	Sertraline Active Medication	Follow-up	28.16	Standard Deviation 14.15	score on a scale
Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	Sertraline Liquid Placebo		68.50	Standard Deviation 11.14	score on a scale
Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score	Sertraline Active Medication		60.03	Standard Deviation 12.15	score on a scale

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline Liquid Placebo	26
Overall Study	STARTED	Sertraline Active Medication	32
Overall Study	Completed End-of-Treatment Visit	Sertraline Liquid Placebo	21
Overall Study	Completed End-of-Treatment Visit	Sertraline Active Medication	26
Overall Study	COMPLETED	Sertraline Liquid Placebo	21
Overall Study	COMPLETED	Sertraline Active Medication	24
Overall Study	NOT COMPLETED	Sertraline Liquid Placebo	5
Overall Study	NOT COMPLETED	Sertraline Active Medication	8

Source ClinicalTrials.gov

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Upper respiratory infection	Infections and infestations	Sertraline Liquid Placebo	19	26	39
other	Upper respiratory infection	Infections and infestations	Sertraline Active Medication	23	32	48
other	Diarrhea	Gastrointestinal disorders	Sertraline Liquid Placebo	15	26	17
other	Diarrhea	Gastrointestinal disorders	Sertraline Active Medication	8	32	11
other	Hyperactivity	Psychiatric disorders	Sertraline Liquid Placebo	9	26	13
other	Hyperactivity	Psychiatric disorders	Sertraline Active Medication	12	32	14
other	Sleep disturbance	Psychiatric disorders	Sertraline Liquid Placebo	3	26	3
other	Sleep disturbance	Psychiatric disorders	Sertraline Active Medication	10	32	14
other	Irritability/Aggression	Psychiatric disorders	Sertraline Liquid Placebo	10	26	11
other	Irritability/Aggression	Psychiatric disorders	Sertraline Active Medication	7	32	9

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sertraline Liquid Placebo	0	26
Total, all-cause mortality	Sertraline Active Medication	0	32
Total, other adverse events	Sertraline Liquid Placebo	26	26
Total, other adverse events	Sertraline Active Medication	30	32
Total, serious adverse events	Sertraline Liquid Placebo	0	26
Total, serious adverse events	Sertraline Active Medication	1	32

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31780970	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sertraline Active Medication vs Sertraline Liquid Placebo: deaths from any cause	Trial comparisons
Sertraline Active Medication vs Sertraline Liquid Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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