VCFS: The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

• Sponsor: The Chaim Sheba Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00768820
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Duration (Months): 259
• Patients Per Site Per Month: 1.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Velocardiofacial Syndrome; Williams Syndrome; Fragile X Syndrome	Drug: methylphenidate, fluoxetin, risperidone	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: May 1, 2001
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: methylphenidate, fluoxetin, risperidone; first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate

Outcome Measures

Primary Outcome Measures

1. Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• chromosomal deletion proven by FISH examination

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schneider Children's Mediac Center of Israel	Petach-Tikva		Israel	49202

Sponsors and Collaborators

• The Chaim Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Doron Gothelf, Principal Investigator, The Chaim Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT00768820
• Other Study ID Numbers: SCMCI082455CTIL
• First Posted: Oct 8, 2008
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Prof. Doron Gothelf, Principal Investigator, The Chaim Sheba Medical Center: Velocardiofacial syndrome; Williams syndrome; fragile X syndrome; cognitive phenotype; psychiatric phenotype
• Additional relevant MeSH terms: DiGeorge Syndrome; Fragile X Syndrome; Williams Syndrome; Syndrome; Risperidone; Methylphenidate

Study Results

No Results Posted as of Mar 9, 2022