ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

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: Placebo

Drug: Sertraline

Primary Outcome(s)

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

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

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

Secondary Outcome(s)

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

Eye Tracking [Time Frame: At baseline 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 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]

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]

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]

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

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

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

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

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.