The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2012 by Rabin Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT00768820

First received: October 7, 2008

Last updated: May 31, 2012

Last verified: May 2012

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 branchio-oculo-facial syndrome CASK-related intellectual disability Crouzon syndrome fragile X syndrome MECP2 duplication syndrome PPM-X syndrome Renpenning syndrome supravalvular aortic stenosis tetrasomy 18p Williams syndrome

MedlinePlus related topics: Fragile X Syndrome

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

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

U.S. FDA Resources

Further study details as provided by Rabin 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 2012
Estimated Primary Completion Date:	December 2012 (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


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	972-03-9253186	gothelf@post.tau.ac.il

Locations


Israel
Schneider Children's Mediac Center of Israel	Recruiting
Petach-Tikva, Israel, 49202
Contact: Doron Gothelf, MD 972-03-9253186

Sponsors and Collaborators

Rabin Medical Center

More Information

No publications provided


Responsible Party:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00768820 History of Changes
Other Study ID Numbers:	SCMCI082455CTIL
Study First Received:	October 7, 2008
Last Updated:	May 31, 2012
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rabin Medical Center:


Velocardiofacial syndrome Williams syndrome fragile X syndrome cognitive phenotype psychiatric phenotype

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015

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