ClinicalTrials.gov record NCT00768820

The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.

SexAll

LocationIsrael

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This diagnostic study examines psychiatric and cognitive characteristics in people with Velocardiofacial syndrome (VCFS), Williams syndrome (WS), and Fragile X syndrome. It combines psychological testing and molecular tests with use of study medications (methylphenidate, fluoxetin, risperidone) in a single-group design. Cognitive testing is done without and then with methylphenidate; outcomes include psychological measures, molecular tests, and responsiveness to medical treatments over two years.

What it is studying. The study is testing psychiatric and cognitive profiles and their links to developmental and molecular factors in VCFS, WS, and Fragile X, and it measures how these profiles and test results respond to medications (methylphenidate, fluoxetin, risperidone).

What the researchers hope to learn. To describe and characterize psychiatric and cognitive phenotypes in VCFS, WS, and Fragile X; to collect molecular data tied to these profiles; and to assess responsiveness to methylphenidate, fluoxetin, and risperidone.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: methylphenidate, fluoxetin, risperidone

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

chromosomal deletion proven by FISH examination

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will undergo cognitive and psychiatric evaluations using psychological measures and will have molecular tests; the study also assesses responsiveness to medical treatments over a reported 2‑year timeframe. The registry lists study drugs (methylphenidate, fluoxetin, risperidone); the protocol notes at least one cognitive evaluation without methylphenidate and a second with methylphenidate. Exact visit schedule, other procedures, and detailed risks or requirements are not specified in the registry and would be provided by the study team.

How the study is structured. Interventional, single-group, open-label (no masking) diagnostic study in Phase 4. All participants follow the same protocol of psychological assessments, molecular testing, and exposure to study medications; cognitive evaluations are repeated before and after methylphenidate.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in Israel. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on fragile X syndrome

Clinical trials20 trials listed for fragile X syndromeEvery trial the registry lists for fragile X syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in fragile X syndrome researchLatest monthly update: September 2026. Includes: Multiple behavior challenges. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 2001
Primary completion: August 2027 (estimated)
Study completion: August 2027 (estimated)
Target enrollment: 400 participants (estimated)
Last updated on registry: Mar 18, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: The Chaim Sheba Medical Center
Principal investigator: Prof. Doron Gothelf, Principal Investigator
The Chaim Sheba Medical Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Doron Gothelf, MD 📞 972-03-5302663 ✉ gothelf@post.tau.ac.il

Participating sites (1)

Schneider Children's Mediac Center of IsraelRecruiting
Petah Tikva, 49202 · Israel
- Doron Gothelf, MD · 972-03-5302663

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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