Trial · NCT01474746

Trial of Sertraline to Treat Children With Fragile X Syndrome

NCT01474746, Phase 2, Completed, Randi J. Hagerman, MD; results first posted 2017-09-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trial of Sertraline to Treat Children With Fragile X Syndrome. Trials, record NCT01474746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474746

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Trial

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

Title: Trial of Sertraline to Treat Children With Fragile X Syndrome
NCT number: NCT01474746
Status: Completed
Phases: Phase 2
Enrollment: 57 participants, actual
Lead sponsor: Randi J. Hagerman, MD
Conditions: Fragile X Syndrome
Interventions: Sertraline, Placebo
First posted: 2011-11-18
Last updated: 2017-09-25
Results first posted: 2017-09-25
Limitations and caveats: Several secondary analyses. Subject non-compliance with eye tracking led to unreliable/uninterpretable data. Subjects and caregivers were unblinded at the time they completed the study. Limited number of girls in the study (total 9 girls).

Source ClinicalTrials.gov

Registered outcomes29

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	Clinical Global Impression - Improvement	6-month follow-up visit score	The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit.
Primary	Change in Mullen Scales of Early Learning - Expressive Language Standard T 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. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
Secondary	Autism Diagnostic Observation Schedule	At baseline visit	The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.
Secondary	Visual Analog Scale	At baseline visit	The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with "worst behavior" at 0 cm and "best behavior" at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the "worst behavior" side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm.
Secondary	Eye Tracking	At baseline visit	There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.
Secondary	Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total 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 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, as well as 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	Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score	At baseline visit	The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure 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. 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, 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 Profile - Sensation Seeking Subscale Raw Score	At baseline visit	The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the "Sensation Seeking" subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others.
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 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.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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.	Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent	units on a scale	MEAN
PRIMARY	Clinical Global Impression - Improvement	6-month follow-up visit score	Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent	units on a scale	MEAN
PRIMARY	Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	From baseline visit to six-month visit	Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent	T scores	MEAN
SECONDARY	Autism Diagnostic Observation Schedule	At baseline visit	The ADOS was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.	units on a scale	MEAN
SECONDARY	Visual Analog Scale	At baseline visit		centimeters	MEAN
SECONDARY	Eye Tracking	At baseline visit	Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.	seconds	MEAN
SECONDARY	Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score	At baseline visit		units on a scale	MEAN
SECONDARY	Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score	At baseline visit	The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 1 subject in the active treatment group at baseline.	units on a scale	MEAN
SECONDARY	Sensory Profile - Sensation Seeking Subscale Raw Score	At baseline visit	The Sensory Profile was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.	units on a scale	MEAN
SECONDARY	Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score	At baseline visit	This assessment was introduced to the protocol partway through the study, and therefore there were only 20 subjects (10 placebo and 10 active) who were administered the Vineland-II at both their baseline and follow-up visits.	units on a scale	MEAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group60

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	Placebo	Baseline	19.3	Standard Deviation 9.68	units on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Active	Baseline	21.3	Standard Deviation 10.32	units on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Placebo	Follow-Up	21.3	Standard Deviation 9.59	units on a scale
Change in Mullen Scales of Early Learning - Expressive Language Raw Score	Active	Follow-Up	25.04	Standard Deviation 10.78	units on a scale
Clinical Global Impression - Improvement	Placebo		2.59	Standard Deviation 0.84	units on a scale
Clinical Global Impression - Improvement	Active		2.28	Standard Deviation 1.06	units on a scale
Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	Placebo	Baseline	23.3	Standard Deviation 5.8	T scores
Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	Active	Baseline	25.8	Standard Deviation 11.78	T scores
Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	Placebo	6-Month Follow-Up	22.6	Standard Deviation 6.47	T scores
Change in Mullen Scales of Early Learning - Expressive Language Standard T Score	Active	6-Month Follow-Up	25.8	Standard Deviation 10.87	T scores

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	30
Overall Study	STARTED	Active	27
Overall Study	COMPLETED	Placebo	27
Overall Study	COMPLETED	Active	25
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Active	2

Source ClinicalTrials.gov

Adverse events68

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	Tantrums	Psychiatric disorders	Placebo	1	30	1
other	Tantrums	Psychiatric disorders	Active	0	27	0
other	Tremor	Nervous system disorders	Placebo	1	30	1
other	Tremor	Nervous system disorders	Active	0	27	0
other	Self-injurious behavior	Injury, poisoning and procedural complications	Placebo	1	30	1
other	Self-injurious behavior	Injury, poisoning and procedural complications	Active	0	27	0
other	Seizures	Nervous system disorders	Placebo	1	30	1
other	Seizures	Nervous system disorders	Active	0	27	0
other	Hand flapping	Psychiatric disorders	Placebo	1	30	1
other	Hand flapping	Psychiatric disorders	Active	0	27	0

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	30
Total, all-cause mortality	Active	0	27
Total, other adverse events	Placebo	26	30
Total, other adverse events	Active	25	27
Total, serious adverse events	Placebo	0	30
Total, serious adverse events	Active	0	27

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Active vs Placebo: deaths from any cause	Trial comparisons
Active vs 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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