The Psychiatric and Cognitive Phenotypes in Velocardiofac... | NCT00768820

Studies
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

NCT00768820

Sponsor

The Chaim Sheba Medical Center

Status

Recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

400Estimated

Phase

Phase 4

Conditions

Velocardiofacial Syndrome
Williams Syndrome
Fragile X Syndrome

Interventions

methylphenidate, fluoxetin, risperidone

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Doron Gothelf, Principal Investigator, The Chaim Sheba Medical CenterPrincipal Investigator

Lead Sponsor

The Chaim Sheba Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: methylphenidate, fluoxetin, risperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methylphenidate, fluoxetin, risperidone	Drug	first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chromosomal deletion proven by FISH examination

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doron Gothelf, MD	Contact	972-03-5302663		gothelf@post.tau.ac.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Children's Mediac Center of Israel	Recruiting	Petah Tikva		49202	Israel

Condition Browse Module

MeSH Terms

ID	Term
D004062	DiGeorge Syndrome
D018980	Williams Syndrome
D005600	Fragile X Syndrome

Ancestor Terms

ID	Term
D058165	22q11 Deletion Syndrome
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate
D005473	Fluoxetine
D018967	Risperidone

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided