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The 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
The Chaim Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 7, 2008
Last Updated
March 8, 2022
Sponsor
The Chaim Sheba Medical Center
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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

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