Velocardiofacial SyndromePhase 4VCFSNCT00768820
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
A Phase 4 study testing methylphenidate, fluoxetin, risperidone in people with Velocardiofacial Syndrome and Williams Syndrome, run by The Chaim Sheba Medical Center at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome
- What is being tested?
- methylphenidate, fluoxetin, risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- May 2001to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chromosomal deletion proven by FISH examination
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Mediac Center of Israel
Petah Tikva, 49202
Doron Gothelf, MD, 972-03-5302663
About this 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
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
- Being tested
- methylphenidate, fluoxetin, risperidone
- Keywords
- Velocardiofacial syndrome, Williams syndrome, fragile X syndrome, cognitive phenotype, psychiatric phenotype
- Medical subject headings
- DiGeorge Syndrome, Williams Syndrome, Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate, fluoxetin, risperidoneDrug
first cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methylphenidate, fluoxetin, risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startMay 2001
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velocardiofacial SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Doron Gothelf, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768820
- Sponsor's protocol ID
- SCMCI082455CTIL
- Acronym
- VCFS
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2008
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00768820
- Acronym / sponsor ID
- VCFS / SCMCI082455CTIL
- Keywords
- Velocardiofacial syndrome, Williams syndrome, fragile X syndrome, cognitive phenotype, psychiatric phenotype
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methylphenidate, fluoxetin, risperidone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chromosomal deletion proven by FISH examination
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate, fluoxetin, risperidonefirst cognitive evaluation without methylphenidate,second cognitive evaluation with methylphenidate | Drug | 1 |
Primary outcome
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Velocardiofacial Syndrome
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
RecruitingObservational study
Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome
DiGeorge Syndrome, 22q11.2 Deletion Syndrome
RecruitingPhase 2
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Neurodevelopmental Disorders, Autism
Enrolling by invitation
Parent and Infant Inter(X)Action Intervention (PIXI)
Fragile X Syndrome, Angelman Syndrome
RecruitingPhase 2
Hematopoietic Stem Cell Transplantation (HSCT) for Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD)
Common Variable Immunodeficiency (CVID), Primary Immune Regulatory Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylphenidate, fluoxetin, risperidone in people with Velocardiofacial Syndrome and Williams Syndrome, run by The Chaim Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doron Gothelf, MD (972-03-5302663, gothelf@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.