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The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

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ClinicalTrials.gov Identifier: NCT00768820
Recruitment Status : Recruiting
First Posted : October 8, 2008
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Doron Gothelf, The Chaim Sheba Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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 2001
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: methylphenidate, fluoxetin, risperidone
first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate


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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chromosomal deletion proven by FISH examination

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Prof. Doron Gothelf, 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