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Trial of Sertraline to Treat Children With Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT01474746
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Randi J. Hagerman, MD, University of California, Davis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Fragile X Syndrome
Interventions: Drug: Sertraline
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

Active

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.


Participant Flow:   Overall Study
    Placebo   Active
STARTED   30   27 
COMPLETED   27   25 
NOT COMPLETED   3   2 
Lost to Follow-up                1                1 
Withdrawal by Subject                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

Active

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Total Total of all reporting groups

Baseline Measures
   Placebo   Active   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   27   57 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      30 100.0%      27 100.0%      57 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  10.0%      6  22.2%      9  15.8% 
Male      27  90.0%      21  77.8%      48  84.2% 
Region of Enrollment 
[Units: Participants]
     
United States   30   27   57 


  Outcome Measures

1.  Primary:   Change in Mullen Scales of Early Learning - Expressive Language Raw Score   [ Time Frame: From baseline visit to six-month visit. ]

2.  Primary:   Clinical Global Impression - Improvement   [ Time Frame: 6-month follow-up visit score ]

3.  Primary:   Change in Mullen Scales of Early Learning - Expressive Language Standard T Score   [ Time Frame: From baseline visit to six-month visit ]

4.  Secondary:   Autism Diagnostic Observation Schedule   [ Time Frame: At baseline visit ]

5.  Secondary:   Visual Analog Scale   [ Time Frame: At baseline visit ]

6.  Secondary:   Eye Tracking   [ Time Frame: At baseline visit ]

7.  Secondary:   Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score   [ Time Frame: At baseline visit ]

8.  Secondary:   Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score   [ Time Frame: At baseline visit ]

9.  Secondary:   Sensory Profile - Sensation Seeking Subscale Raw Score   [ Time Frame: At baseline visit ]

10.  Secondary:   Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score   [ Time Frame: At baseline visit ]

11.  Secondary:   Mullen Scales of Early Learning - Visual Reception Raw Score   [ Time Frame: At baseline visit ]

12.  Secondary:   Mullen Scales of Early Learning - Fine Motor Raw Score   [ Time Frame: At baseline visit ]

13.  Secondary:   The Autism Diagnostic Observation Schedule (ADOS-2)   [ Time Frame: At six month visit ]

14.  Secondary:   The Visual Analog Scale   [ Time Frame: At six-month visit ]

15.  Secondary:   Eye Tracking   [ Time Frame: At six-month visit ]

16.  Secondary:   Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score   [ Time Frame: At six-month visit ]

17.  Secondary:   Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score   [ Time Frame: At six-month visit ]

18.  Secondary:   Sensory Profile - Sensation Seeking Subscale Raw Score   [ Time Frame: At six-month visit ]

19.  Secondary:   Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score   [ Time Frame: At six-month visit ]

20.  Secondary:   Mullen Scales of Early Learning - Visual Reception Raw Score   [ Time Frame: At six-month visit ]

21.  Secondary:   Mullen Scales of Early Learning - Visual Reception Age-equivalent Score   [ Time Frame: At baseline visit ]

22.  Secondary:   Mullen Scales of Early Learning - Visual Reception Age-equivalent Score   [ Time Frame: At six-month visit ]

23.  Secondary:   Mullen Scales of Early Learning - Fine Motor Raw Score   [ Time Frame: At six-month visit ]

24.  Secondary:   Mullen Scales of Early Learning - Fine Motor Age-equivalent Score   [ Time Frame: At baseline visit ]

25.  Secondary:   Mullen Scales of Early Learning - Fine Motor Age-equivalent Score   [ Time Frame: At six-month visit ]

26.  Secondary:   Mullen Scales of Early Learning - Cognitive T Score Sum   [ Time Frame: At baseline visit ]

27.  Secondary:   Mullen Scales of Early Learning - Cognitive T Score Sum   [ Time Frame: At six-month visit ]

28.  Secondary:   Mullen Scales of Early Learning - Summary Age-equivalent Score   [ Time Frame: At baseline visit ]

29.  Secondary:   Mullen Scales of Early Learning - Summary Age-equivalent Score   [ Time Frame: At six-month visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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).


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Randi Hagerman
Organization: University of California, Davis, MIND Institute
phone: 916-703-0247
e-mail: rjhagerman@ucdavis.edu



Responsible Party: Randi J. Hagerman, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01474746     History of Changes
Other Study ID Numbers: 271070
R40MC22641 ( Other Grant/Funding Number: Health Resources and Services Administration (HRSA) )
First Submitted: November 10, 2011
First Posted: November 18, 2011
Results First Submitted: March 27, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017