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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01474746
Date of registration:	10/11/2011
Prospective Registration:	Yes
Primary sponsor:	Randi J. Hagerman, MD
Public title:	Trial of Sertraline to Treat Children With Fragile X Syndrome
Scientific title:	A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome
Date of first enrolment:	January 2012
Target sample size:	57
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01474746
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase:	Phase 2

Countries of recruitment
United States

Contacts

Name:	Randi J Hagerman, MD
Address:
Telephone:
Email:
Affiliation:	UC Davis MIND Institute

Name:	Kathleen Angkustsiri, MD
Address:
Telephone:
Email:
Affiliation:	UC Davis MIND Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fragile X Syndrome

Exclusion Criteria:

- Current or past SSRI treatment

- Current or past MAOI (monoamine oxidase inhibitor ) treatment

- Serious co-morbid medical disorder affecting brain function and behavior (not
including fragile X syndrome).

- Uncontrolled seizure disorder or epilepsy

- Bipolar disorder

- Latex allergies

Age minimum: 24 Months
Age maximum: 68 Months
Gender: All

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: Sertraline

Drug: Placebo

Primary Outcome(s)

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

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

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

Secondary Outcome(s)

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

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

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

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

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

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

Visual Analog Scale [Time Frame: At baseline visit]

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

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

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

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

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

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

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

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

Eye Tracking [Time Frame: At baseline visit]

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

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

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

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

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

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

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

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

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

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

Secondary ID(s)

271070

R40MC22641

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	25/09/2017
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01474746

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