Trial · NCT06465823
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual-Object long-term memory measures | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Visual-Object Learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term visual memory skills.The total raw score of the visual episodic memory trial, the raw learning scores for each immediate recall trial (R\_Score T1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be evaluated. |
| Secondary | Verbal long-term memory measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Verbal Learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term verbal memory skills. The raw learning scores for each immediate recall trial (R\_ScoreT1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be taken into account. |
| Secondary | Visual-Spatial long-term memory measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Visual-Spatial learning test (PROMEA, Vicari, 2007) - Efficacy criterion. Test assesses long-term spatial memory skills.The raw learning scores for each immediate recall trial (R\_ScoreT1, T2, T3) and the raw score of the deferred recall trial (R\_ Score Deferred) will be taken into account. |
| Secondary | Long-term memory measures : recollection and familiarity | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Processing Dissociation Procedure - PDP (Costanzo et al., 2013 - Efficacy criterion. Test assesses recollection and familiarity processes to memory performance..In the Processing Dissociation Procedures (PDP) test, of hits alarms responses (H) and false alarms responses (F) will be considered for both the "Inclusion" and "Exclusion" conditions. |
| Secondary | Long-term memory measure: associative memory | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Associative Memory (Costanzo et al., 2013) - Efficacy criterion. Test assesses recollection and familiarity processes to memory performance.The total raw scores for the "single item" and "associative item" condition and the learning raw scores for each trial of each condition (T1, T2, T3) will be evaluated. |
| Secondary | Long-term measure - child's everyday memory | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | The Observer Memory Questionnaire-Parent Form (OMQ-PF, Gonzalez et al., 2008) - Likert scale questionnaire, test assesses parental beliefs about their child's everyday memory.For the assessment of everyday memory skills, the raw total score will be considered. |
| Secondary | Adaptive level | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | ABAS II (Adaptive Behavior Assessment System Second Edition, Italian adaptation of Ferri R., Orsini A. e Rea M., Eds., 2014) - Efficacy criterion. Scale to obtain the parent's observations about the youth's behaviour and gives a complete overview of child and adolescent adaptive behaviours. |
| Secondary | Executive measure | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Behavior Rating Inventory Executive Function Second Edition (BRIEF 2, Gioia et al., 2000) Inventory evaluates everyday behaviors associated with EF in home and educational environments.The standardized scores (T) of Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task-Monitor,and Organization of Materials scales will be evaluated. Behavioral Regulation Index (BRI), Emotional Regulation Index (ERI), Cognitive Regulation Index (CRI) and Global Executive Composite Score (GEC) also will be assessed. |
| Secondary | Psychopathological measure - semi-structured diagnostic interview | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | K-Sads-Present and Lifetime Version (K-SADS-PL) (Kaufman et al., 2004) - Efficacy criterion. Interview assesses psychopathology according to the DSM-5 criteria.The total raw score related to current symptoms reported by the participant's parents in the interview and the symptom/disease decoding scores related to each diagnostic category will be evaluated. |
| Secondary | Psychopathological measure - behavioral and psychopathological aspects | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Conners' Parent Rating Scale -. Revised, Long Form (CPRS-R:L - Conners, 1997; Nobile, Alberti, \& Zuddas, 2007) - Efficacy criterion. Questionnaire used parent's observations about the youth's behaviour and gives a complete overview of child and adolescent psychopathological disorders.The T scores of each scale of the questionnaire will also be evaluated. |
| Secondary | Psychopathological measure - quantitative scale on anxiety symptoms | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Multidimensional Anxiety Scale For Children - (MASC-parent report form March, 1997) - Efficacy criterion. Questionnaire assesses anxiety symptoms.The standardized total score (T) and T scores of the separation anxiety (SP), GAD, social anxiety (SAT), obsessions and compulsions (OC), physical symptoms (PS:T) and harm avoidance (HA) scales will be evaluated. |
| Secondary | Psychopathological measure - behavioural and emotional problems | Change from baseline (day 1) to 3 month (day 90 ± 3), day 150 ± 4 | Child Behavior Checklist for Ages 6-18 - CBCL/6-18 (Achenbach e Rescorla, 2001) - Efficacy criterion. Questionnaire assesses behavioural and emotional problems in children and young people aged 6-18 years.The T-scores of each scale of the CBCL 6-18 questionnaire will be evaluated. |
| Secondary | Quality of life | day 1/ day 7± 1/ day 31± 3/day 90 ± 3/day, day 150 ± 4 | PedsQL (PedsQL, JWVarni, 2004): measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. the raw scores of each scale (Physical , Emotional , Social , School) and the respective mean scores (Physical SC, Emotional Functioning ,Social Functioning , School Functioning), the physical index (T\_Physical) , the psychosocial index (T\_Psychosocial) and the mean total score (Total Score) of the questionnaire, will be evaluated. |
| Secondary | Quality of sleep | day 1/ day 7± 1/ day 31± 3/day 90 ± 3/day, day 150 ± 4 | Sleep Disorders SDSC (The Sleep Disturbance Scale for Children, Bruni et al., 1996) - Sleepiness inventory is used to obtain the parent's observations about sleep disorders in children in five subdomains.T scores of each scale will be evaluated. |
| Secondary | Bristol stool scale | Day 1, Day 7± 1, Day 31± 3, Day 90 ± 3, Day 150 ± 4 | Quality of life Stooling (based on Bristol stool scale) - Diagnostic medical tool designed to classify the form of human faeces into seven categories (Type 1-7) |
| Other | Biosample PBMC (blood) for biomarkers | Day 1 and Day 90 ±3 | Exploratory end-point - PBMCs will be analyzed from blood samples of all patients to identify possible biomarkers for response to treatment by evaluating the expression of NKCC1 and other genes (at RNA or protein levels) |
| Other | Transcriptomic analysis by RNA-Seq assessment (on PBMCs samples) | Day 1, Day 90 ±3 and Day 150 ±4 | Exploratory end-point - All cohort patients will be analyzed for transcriptomic analysis by RNA-Seq. Total mRNA will be purified from PBMC and used for the mRNA-Seq library preparation |
| Other | Genomic assessment (on blood samples) | Day 1 | Exploratory end-point - All participants will be analyzed by whole genome sequencing (both patients who respond to therapy and those who do not show any positive response). Genomic analysis will be performed on the pellet derived from centrifugation of the blood samples collected at visit 1, to obtain the corresponding plasma samples to be used for the proteomic analysis. |
| Other | Proteomic (on plasma and PBMCs samples) assessment | Day 1, Day 90 ± 3 and Day 150 ± 4 | Exploratory end-point. Plasma and PBMC samples will be collected from all patients (both patients who respond to therapy and those who do not show any positive response). Five mL of peripheral venous blood samples x (supernatant) will be collected. |
| Other | Metabolomic (on urine samples) assessment | Day 1, Day 90 ± 3 and Day 150 ± 4 | Exploratory end-point: Urine samples will be collected from all patients (both patients who respond to therapy and those who do not show any positive response) to identify possible biomarkers for treatment response |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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