Text Size

The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

This study is currently recruiting participants.
Verified May 2012 by Rabin Medical Center
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:

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
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:
Fragile X Syndrome
Mental Retardation, X-Linked
Genetic Diseases, X-Linked
Williams Syndrome
DiGeorge Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
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
Abnormalities, Multiple
Hypoparathyroidism
Parathyroid Diseases

ClinicalTrials.gov processed this record on May 21, 2013