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RecruitingNCT00768820VCFSUpdated Mar 18, 2026

The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

A Phase 4 interventional study of methylphenidate, fluoxetin, risperidone in Velocardiofacial Syndrome, Williams Syndrome and Fragile X Syndrome, sponsored by The Chaim Sheba Medical Center. Recruiting at 1 site in Israel. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by The Chaim Sheba Medical Center · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Sex
All
01

Study 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

02

Conditions studied

  • Velocardiofacial Syndrome
  • Williams Syndrome
  • Fragile X Syndrome

Keywords

  • Velocardiofacial syndrome
  • Williams syndrome
  • fragile X syndrome
  • cognitive phenotype
  • psychiatric phenotype
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • chromosomal deletion proven by FISH examination

Exclusion criteria

Exclusion Criteria:

04

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    1

    Drug: methylphenidate, fluoxetin, risperidone

Interventions

  • Drugmethylphenidate, fluoxetin, risperidone

    first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate

05

What researchers measure

Primary outcomes

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

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Schneider Children's Mediac Center of Israel
    Petah Tikva, 49202, Israel
    • Doron Gothelf, MD · Contact · 972-03-5302663
    Recruiting
07

Registry details

Key details

Study ID
NCT00768820
Lead sponsor
The Chaim Sheba Medical Center
Responsible party
Prof. Doron Gothelf (Principal Investigator, The Chaim Sheba Medical Center) — Principal investigator
First posted
Oct 8, 2008
Start date
May 2001
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Doron Gothelf, MD
Contact
gothelf@post.tau.ac.il
972-03-5302663

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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