Trial · NCT04623398
Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency)
NCT04623398, Phase 3, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency). Trials, record NCT04623398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04623398
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency)
- NCT number
- NCT04623398
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Autism Spectrum Disorder
- Interventions
- Lithium Carbonate, Placebo
- First posted
- 2020-11-10
- Last updated
- 2025-10-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Score social responsiveness scale | 12 weeks | Severity of Autistic Symptoms - Social Responsiveness Scale - Total score at 12 weeks. |
| Secondary | Score social responsiveness scale | Baseline (At randomization) , 4 weeks, 8 weeks, and 16 to 18 weeks after stopping the treatment | Severity of Autistic Symptoms - Social Responsiveness Scale. Evaluate the effect of the treatment on the severity of autistic symptoms. Exploring the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial. |
| Secondary | score of autism diagnosis observation scale | Baseline (At randomization) and 12 weeks | Autism Diagnosis Observation Calibrated Severity Score. Evaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial. |
| Secondary | Score of attention deficit hyperactivity disorder | Baseline (At randomization) 4 weeks, 8 weeks, 12 weeks, and 16 to 18 weeks after stopping the treatment | assessment of hyperactivity. Evaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial. |
| Secondary | score of child's sleep disorder rating scale | Baseline (At randomization) , 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatment | Evaluate the effect of the treatment on Child's Sleep Disorder |
| Secondary | Score of Dunn Sensory Profile | 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatment | Evaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial. |
| Secondary | Score of Aberrant Behavior checklist scale | Baseline (At randomization), 4 weeks, 8 weeks and 12 weeks | Aberrant Behavior Checklist Scale - Social Withdrawal Subscale. Exploring aberrant, stereotyped, repetitive and obsessive behaviours (sub-scores and total score) and co-morbidities |
| Secondary | score of global functioning | Baseline (At randomization), 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatment | Clinical Global Improvement - Improvement and Severity Scores. Evaluate the effect of the treatment on the global functioning of patients and the impact on their environment |
| Secondary | Score of Vineland Adaptive Behavior Composite | Baseline (At randomization) and12 weeks | Evaluate the effect of the treatment on the global functioning of patients and the impact on their environment |
| Secondary | Score of surrounding constraints | Baseline (At randomization), 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatment | Surrounding Constraints - Caregiver Strain Index. Evaluate the effect of the treatment on the global functioning of patients and the impact on their environment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04623398
GET https://conductscience.org/api/trials/v1/NCT04623398/registered