Back to resultsThe Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)
Primary Purpose
Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome
Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
methylphenidate, fluoxetin, risperidone
Sponsored by
About this trial
This is an interventional diagnostic trial for Velocardiofacial Syndrome focused on measuring Velocardiofacial syndrome, Williams syndrome, fragile X syndrome, cognitive phenotype, psychiatric phenotype
Eligibility Criteria
Inclusion Criteria:
- chromosomal deletion proven by FISH examination
Exclusion Criteria:
Sites / Locations
- Schneider Children's Mediac Center of IsraelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments
Secondary Outcome Measures
Full Information
NCT ID
NCT00768820
First Posted
October 7, 2008
Last Updated
March 8, 2022
Sponsor
The Chaim Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00768820
Brief Title
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
Acronym
VCFS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2001 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Chaim Sheba Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome
Keywords
Velocardiofacial syndrome, Williams syndrome, fragile X syndrome, cognitive phenotype, psychiatric phenotype
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methylphenidate, fluoxetin, risperidone
Intervention Description
first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate
Primary Outcome Measure Information:
Title
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chromosomal deletion proven by FISH examination
Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doron Gothelf, MD
Phone
972-03-5302663
Email
gothelf@post.tau.ac.il
Facility Information:
Facility Name
Schneider Children's Mediac Center of Israel
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doron Gothelf, MD
Phone
972-03-5302663
12. IPD Sharing Statement
Learn more about this trial
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
We'll reach out to this number within 24 hrs