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
  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:


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:
Craniofacial Abnormalities
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
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Lymphatic Abnormalities
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 23, 2016