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The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS)

This study is currently recruiting participants.
Verified by Rabin Medical Center, October 2008

Sponsored by: Rabin Medical Center
Information provided by: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00768820
  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 IV

Genetics Home Reference related topics:   22q11.2 deletion syndrome    familial encephalopathy with neuroserpin inclusion bodies    fragile X syndrome    L1 syndrome    Williams syndrome   

MedlinePlus related topics:   Fragile X Syndrome   

Drug Information available for:   Risperidone    Methylphenidate hydrochloride    Methylphenidate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental 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


Responsible Party:   Rabin Medical Center ( Doron Gothelf )
Study ID Numbers:   SCMCI082455CTIL
First Received:   October 7, 2008
Last Updated:   October 7, 2008
ClinicalTrials.gov Identifier:   NCT00768820
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  

Study placed in the following topic categories:
Chromosomal abnormalities
Parathyroid Diseases
X-linked mental retardation and macro-orchidism
Methylphenidate
Constriction, Pathologic
Fragile X Syndrome
Aortic valve stenosis
Dopamine
Heredodegenerative Disorders, Nervous System
Williams Syndrome
Genetic Diseases, X-Linked
DiGeorge syndrome
Hypoparathyroidism
Aortic Valve Stenosis
Congenital Abnormalities
Velocardiofacial syndrome
Neurobehavioral Manifestations
Heart Diseases
Risperidone
Chromosome Disorders
Endocrine System Diseases
Serotonin
DiGeorge Syndrome
Immunologic Deficiency Syndromes
Heart Valve Diseases
Mental Retardation
Genetic Diseases, Inborn
Fragile X syndrome
Neurologic Manifestations
Endocrinopathy

Additional relevant MeSH terms:
Syndrome
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Disease
Tranquilizing Agents
Immune System Diseases
Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Central Nervous System Stimulants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Aortic Stenosis, Supravalvular
Sex Chromosome Disorders
Dopamine Agents
Mental Retardation, X-Linked
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 10, 2008




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