NCT00768820

Brief Summary

The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
15mo left

Started May 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2001Aug 2027

Study Start

First participant enrolled

May 1, 2001

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
18.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

26.3 years

First QC Date

October 7, 2008

Last Update Submit

March 17, 2026

Conditions

Williams SyndromeFragile X SyndromeVelocardiofacial Syndrome

Keywords

Velocardiofacial syndromeWilliams syndromefragile X syndromecognitive phenotypepsychiatric phenotype

Outcome Measures

Primary Outcomes (1)

  • Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments

    2 years

Study Arms (1)

1

EXPERIMENTAL
Drug: methylphenidate, fluoxetin, risperidone

Interventions

methylphenidate, fluoxetin, risperidoneDRUG

first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chromosomal deletion proven by FISH examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Mediac Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

DiGeorge SyndromeWilliams SyndromeFragile X Syndrome

Interventions

MethylphenidateFluoxetineRisperidone

Condition Hierarchy (Ancestors)

22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System DiseasesIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAortic Stenosis, SupravalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesX-Linked Intellectual DisabilitySex Chromosome DisordersGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesPyrimidinonesPyrimidines

Central Study Contacts

Doron Gothelf, MD

CONTACT

972-03-5302663gothelf@post.tau.ac.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

May 1, 2001

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

IL(1)