Trial · NCT04388774

Low-Dose Ketamine in Children With ADNP Syndrome

NCT04388774, Phase 1, Phase 2, Completed, Alexander Kolevzon; results first posted 2023-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Low-Dose Ketamine in Children With ADNP Syndrome. Trials, record NCT04388774. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04388774

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Low-Dose Ketamine in Children With ADNP Syndrome
NCT number: NCT04388774
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Alexander Kolevzon
Conditions: ADNP Syndrome
Interventions: Ketamine
First posted: 2020-05-14
Last updated: 2023-07-07
Results first posted: 2023-07-07

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With an Adverse Event	Week 4	Number of Participants with an adverse event as defined by the Systematic Longitudinal Assessment of Adverse Events (SLAES) which is a comprehensive form that assesses medical and behavioral conditions that were present at screening and/or baseline. Conditions are considered treatment emergent if their severity increased significantly after the participant had taken at least one dose of the study treatment. Treatment emergent adverse events will be tracked considered in the adverse event safety analysis. Severity of adverse events are categorized as mild, moderate, severe, life-threatening, or resulting in death and the treating physician indicates if the adverse event was related or unrelated to study drug.
Secondary	Aberrant Behavior Checklist	Baseline, Week 1	Changes in scale at week 1 compared to baseline. Aberrant Behavior Checklist is a behavior rating scale for the assessment of treatment effects. Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). Subscales from 0-45 for Irritability; 0-48 for Social Withdrawal and Hyperactivity; from 0-21 for Stereotypy; and 0-12 for In Speech , with total scale from 0 to 48, with higher score indicating worse health outcomes.
Secondary	Anxiety, Depression and Mood Scales (ADAMS)	Baseline and Week 1	The ADAMS is a parent/caregiver-completed measure and consists of 28 items, grouped into five subscales (Manic/Hyperactive Behavior, Depressed Mood, Social Avoidance, General Anxiety, Obsessive Behavior), and scored on a four-point Likert scale that combines frequency and severity ratings from 0-3. Subscales range - Hyperactivity 0-15; Depressed 0-21; Social Avoidance 0-21; General anxiety 0-21; OCD 0-9. Scores are not summed. Higher score indicates poorer health outcomes.
Secondary	Repetitive Behavior Scale-Revised (RBS-R)	Baseline, Week 1	Change in repetitive behaviors at weeks 1 compared to baseline. RBS-R subscales - Stereo 0-18; Self injury 0-24; Compulsive 0-24; Ritualistic 0-18; Sameness 0-33; Restricted 0-12. Total scale range from 0 to 126 with higher score indicating worse health outcomes.
Secondary	Clinical Global Impressions - Improvement Scale (CGI-I)	Baseline, Week 2, and Week 4	Changes in scale at weeks 2, and 4 compared to baseline. Clinical Global impressions - Improvement Scale is anchored to symptoms of ADNP syndrome for the assessment of treatment effects. CGI-I total score from 1 to 7 point scale, with higher score indicating worse health outcomes.
Secondary	Childrens Sleep Habits Questionnaire	Baseline, Week 1	Change in sleep habits at week 1 compared to baseline. Full scale from 0 to 110, with higher score indicating worse health outcomes.
Secondary	Peabody Picture Vocabulary Test and Expressive Vocabulary Test	Baseline, Week 1, Week 2, and Week 4	Expressive and receptive language assessed by Peabody Picture Vocabulary Test and Expressive Vocabulary Test at Day 1, Weeks 1, 2, and 4. Full scale from 40 to 160, with higher score indicating better health outcomes.
Secondary	Proportion of Target-First Trials Saccades	Baseline, Day 1, Week 1	Change at Day 1 and Week 1 as compared to baseline using computerized eye tracking to record where the subject is looking during an activity in which the subject will see a video of a person with two objects, turning her head towards one of the objects, the target. Mean proportion of trials in which participants made saccades to the target before the distractor.
Secondary	Latency to First Saccade	Baseline, Day 1, Week 1	Change at week 1, week 2, and week 4 as compared to baseline using computerized eye tracking to record where the subject is looking during an activity in which the subject will see different social and non-social stimuli. Latency to first saccade to the target
Secondary	Proportion of Target-Dwelling	Baseline, Day 1, Week 1	Change at Day 1 and Week 1 as compared to baseline using computerized eye tracking to record where the subject is looking during an activity in which the subject will see different social and non-social stimuli. Proportion of time participants spent dwelling on the target versus distractor.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With an Adverse Event	Week 4		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Aberrant Behavior Checklist	Baseline, Week 1	Each participant had one caregiver provide rated assessments.	score on a scale	MEAN
SECONDARY	Anxiety, Depression and Mood Scales (ADAMS)	Baseline and Week 1		score on a scale	MEAN
SECONDARY	Repetitive Behavior Scale-Revised (RBS-R)	Baseline, Week 1		score on a scale	MEAN
SECONDARY	Clinical Global Impressions - Improvement Scale (CGI-I)	Baseline, Week 2, and Week 4		score on a scale	MEAN
SECONDARY	Childrens Sleep Habits Questionnaire	Baseline, Week 1		units on a scale	MEAN
SECONDARY	Peabody Picture Vocabulary Test and Expressive Vocabulary Test	Baseline, Week 1, Week 2, and Week 4		score on a scale	MEAN
SECONDARY	Proportion of Target-First Trials Saccades	Baseline, Day 1, Week 1	Not every trial was valid. Eye tracking data were successfully collected from nine participants for the Joint Attention task, but only four participants had \>25% valid trials at all three time points and were included in analysis.	proportion of target-first saccades	MEAN
SECONDARY	Latency to First Saccade	Baseline, Day 1, Week 1	Eye tracking data were successfully collected from nine participants for the Joint Attention task, but only four participants had \>25% valid trials at all three time points and were included in analysis.	ms	MEAN
SECONDARY	Proportion of Target-Dwelling	Baseline, Day 1, Week 1	Eye tracking data were successfully collected from nine participants for the Joint Attention task, but only four participants had \>25% valid trials at all three time points and were included in analysis.	proportion of time	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group79

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With an Adverse Event	Ketamine		9		Participants
Aberrant Behavior Checklist	Caregiver Rated Assessment at Baseline	Irritability	20.5	Standard Deviation 13.33	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at 1 Week	Irritability	10.9	Standard Deviation 10.6	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at Baseline	Social withdrawal	9.9	Standard Deviation 8.96	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at 1 Week	Social withdrawal	4.2	Standard Deviation 4.96	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at Baseline	Motor stereotypies	7.8	Standard Deviation 5.31	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at 1 Week	Motor stereotypies	4.5	Standard Deviation 3.66	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at Baseline	Hyperactivity	24.5	Standard Deviation 14.66	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at 1 Week	Hyperactivity	16.2	Standard Deviation 13.35	score on a scale
Aberrant Behavior Checklist	Caregiver Rated Assessment at Baseline	Inappropriate speech	3.6	Standard Deviation 2.88	score on a scale

1 to 10 of 79Source ClinicalTrials.gov

See all 79 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ketamine	10
Overall Study	COMPLETED	Ketamine	10
Overall Study	NOT COMPLETED	Ketamine	0

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Elated/silly	Psychiatric disorders	Ketamine	5	10
other	Aggression	Psychiatric disorders	Ketamine	4	10
other	Fatigue	Nervous system disorders	Ketamine	4	10
other	Decreased appetite	General disorders	Ketamine	3	10
other	Anxiety	Psychiatric disorders	Ketamine	3	10
other	Increased appetite	General disorders	Ketamine	2	10
other	Restless	Psychiatric disorders	Ketamine	2	10
other	Increased fluid intake	General disorders	Ketamine	2	10
other	Nausea/vomiting	Gastrointestinal disorders	Ketamine	2	10
other	Moody/irritable	Psychiatric disorders	Ketamine	2	10

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ketamine	0	10
Total, other adverse events	Ketamine	9	10
Total, serious adverse events	Ketamine	0	10

Source ClinicalTrials.gov

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.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Vocabulary Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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