Trial · NCT06789783
Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment
NCT06789783, Phase 2, Phase 3, Recruiting, University of Milan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment. Trials, record NCT06789783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06789783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cornelia De Lange Syndrome: Assessing Positive Effects of Lithium Treatment
- NCT number
- NCT06789783
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 34 participants, estimated
- Lead sponsor
- University of Milan
- Conditions
- Cornelia De Lange Syndrome
- Interventions
- Lithium Carbonate Capsule
- First posted
- 2025-01-23
- Last updated
- 2025-01-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Behaviour | Change at 12 months from baseline of supplementation | Behaviour assessed through the Aberrant Behaviour checklist (ABC1 scale) which mesaure psychiatric symptomatology and behavioral disorders also in patients with intellectual disabilities. minimum total score: 0; maximum total score:174. Higher scores mean worse outcome |
| Secondary | Communication | Change at 12 months from baseline of supplementation | Social Communication Questionnaire questionnaire (SCQ; Rutter, Bailey\&Lord, 20032) to assess communication skills and social functioning; minimum score: 0; maximum score:40. Higher score means worse outcome. |
| Secondary | Behaviour | Change at 12 months from baseline of supplementation | Childhood Autism Rating Scale (CARS 2 -T3) to assess autistic behaviors. minimum score: 15; maximum score:60. Higher score means worse outcome. Furthermore, for very serious patients, for whom a direct assessment with the Leiter could be insignificant or impossible, it would allow for the adaptation quotient (QD). |
| Secondary | Sleep disturbances | Change at 12 months from baseline of supplementation | Sleep quality through the Sleep disturbances scale for children (SDSC5), to be administered to parents; there are two versions, one for subjects between 6-16 years, the other for children 3-6 years. minimum total score: 26; maximum total score:130. Higher scores mean worse outcome. |
| Secondary | Clinical features | Change at 12 months from baseline of supplementation | Impression of change Clinical Global Impression of Change (CGI-C) filled out by the clinician at each visit. minimum total score:0; maximum total score:30. Higher scores mean worse outcome. |
| Secondary | Cognitive Performance | Change at 12 months from baseline of supplementation | Cognitive Performance through the Leiter scale (Leiter-R, Roid \& Miller, 19974), a non-verbal scale that can be used for subjects between 2 and 20 years old. We use only cognitive battery and administer only the 4 mandatory subtests: Total raw score: minimum 0, maximum 152 |
| Secondary | Adaptive functioning in the different areas | Change at 12 months from baseline of supplementation | Vineland Adaptive Behavior Scale 2 in order to also assess adaptive functioning in the different areas (motor, communication, autonomy, socialization). minimum total score: 0; maximum total score:766. Higher scores mean better outcome |
| Secondary | Quality of life | Change at 12 months from baseline of supplementation | Improvement in quality of life through Pediatric Quality of Life Inventory (PedsQL6). minimum total score: 0; maximum total score:92. Higher scores mean worse outcome |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33597506 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06789783
GET https://conductscience.org/api/trials/v1/NCT06789783/registered