The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 by The Chaim Sheba Medical Center

Sponsor:

Information provided by (Responsible Party):

Prof. Doron Gothelf, The Chaim Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00768820

First received: October 7, 2008

Last updated: January 28, 2016

Last verified: January 2016

History of Changes

Purpose

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	Intervention	Phase
Velocardiofacial Syndrome Williams Syndrome Fragile X Syndrome	Drug: methylphenidate, fluoxetin, risperidone	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 22q11.2 deletion syndrome CASK-related intellectual disability Crouzon syndrome MECP2 duplication syndrome PPM-X syndrome Renpenning syndrome SYNGAP1-related intellectual disability Williams syndrome branchio-oculo-facial syndrome fragile X syndrome supravalvular aortic stenosis

MedlinePlus related topics: Fragile X Syndrome

Drug Information available for: Methylphenidate Methylphenidate hydrochloride Risperidone

Genetic and Rare Diseases Information Center resources: Fragile X Syndrome X-linked Mental Retardation and Macro-orchidism 22q11.2 Deletion Syndrome Williams Syndrome Aortic Valve Stenosis Lymphatic Malformations Hypoparathyroidism

U.S. FDA Resources

Further study details as provided by The Chaim Sheba Medical Center:

Primary Outcome Measures:

Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	400
Study Start Date:	May 2001
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: methylphenidate, fluoxetin, risperidone first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

chromosomal deletion proven by FISH examination

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768820

Contacts


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

Locations


Israel
Schneider Children's Mediac Center of Israel	Recruiting
Petach-Tikva, Israel, 49202
Contact: Doron Gothelf, MD 972-03-5302663

Sponsors and Collaborators

The Chaim Sheba Medical Center

More Information


Responsible Party:	Prof. Doron Gothelf, Principal Investigator, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00768820 History of Changes
Other Study ID Numbers:	SCMCI082455CTIL
Study First Received:	October 7, 2008
Last Updated:	January 28, 2016
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by The Chaim Sheba Medical Center:


Velocardiofacial syndrome Williams syndrome fragile X syndrome cognitive phenotype psychiatric phenotype

Additional relevant MeSH terms:


Syndrome Fragile X Syndrome Williams Syndrome DiGeorge Syndrome Disease Pathologic Processes Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Sex Chromosome Disorders Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn	Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Aortic Stenosis, Supravalvular Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases 22q11 Deletion Syndrome Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Heart Defects, Congenital Cardiovascular Abnormalities Lymphatic Abnormalities Lymphatic Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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