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The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768820
Recruitment Status : Recruiting
First Posted : October 8, 2008
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Doron Gothelf, The Chaim Sheba Medical Center

Study Description
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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
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 2001
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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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Ages Eligible for Study:   Child, Adult, Older Adult
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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Information from the National Library of Medicine

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

Locations
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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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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Prof. Doron Gothelf, Principal Investigator, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00768820    
Other Study ID Numbers: SCMCI082455CTIL
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
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:
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DiGeorge Syndrome
Craniosynostoses
Marfan Syndrome
Arachnodactyly
Fragile X Syndrome
Williams Syndrome
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
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
22q11 Deletion Syndrome
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases