Lisdexamfetamine For the Treatment of Conduct Disorder in Children
NCT07923617, Phase 2, Not yet recruiting, Orygen
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lisdexamfetamine For the Treatment of Conduct Disorder in Children | ClinicalTrials.gov |
| NCT number | NCT07923617 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Orygen | ClinicalTrials.gov |
| Conditions | Conduct Disorder | ClinicalTrials.gov |
| Interventions | Lidexamfetamine | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Nisonger Child Behavior Rating Form - Conduct Problem scale | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | The parent version of the NCBRF consists of 16 items, rated 0 (Not True), 1 (Sometimes True), 2 (Often True) or 3 (Always True). It will assess a range of behaviours in the past week. It has a number of subscales including Conduct Disorder, Insecure, Anxious Hyperactive, Self-Injury/Stereotypic, Self-Isolated/Ritualistic, Overly Sensitive subscales. The Conduct Disorder subscale will be used as primary outcome measure. This is a self-report. | ClinicalTrials.gov |
| Secondary | Adverse events | From enrollment to the end of study at Day 51 | All adverse events that arise during the study will be collected | ClinicalTrials.gov |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | At baseline and at Research Assessment 1 (Day 10), Medical Review 1 (Day 17), Assessment 2 (Day 27), Medical Review 1 (Day 34), Research Assessment 3 (Day 44) and End of Study Assessment (Day 51). | The C-SSRS supports suicide risk assessment through a series of simple, plain-language questions. The answers help the interviewer to identify at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. | ClinicalTrials.gov |
| Secondary | Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | The PROMIS-SD is an 8-item short form self-report of perception of sleep quality, depth and restoration within the past seven days. This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction. The measure uses a 5-point Likert scale, and the raw score can be converted to a standardized T-score using conversion tables, with higher scores indicating greater sleep/wake disturbances. The adult PROMIS-SD has demonstrated adequate content validity in children and adolescents. | ClinicalTrials.gov |
| Secondary | Timeline Follow Back (TLFB) | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | A calendar method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of alcohol, cannabis and other drug use. The TLFB will be interviewer administered and will involve asking participants to retrospectively estimate their alcohol, cannabis and other drug use since the most recent assessment (past 30 days for screening). | ClinicalTrials.gov |
| Secondary | Assessment of Quality of Life - 6 Dimension - Adolescent (AQoL-6D-A) | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | A self-reported instrument designed to assess health-related quality of life. The AQoL-6D-A consists of 20-item self-report questionnaire which assesses the quality of life relative to six dimensions: Independent Living, Mental Health, Coping, Relationships, Pain and Senses. These six domains may be combined to form a single global QoL factor. | ClinicalTrials.gov |
| Secondary | SNAP-IV Teacher and Parent Rating Scale | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | The SNAP-IV is a self-reported tool to assess for ADHD symptoms. Parents or guardians of participants will complete it. | ClinicalTrials.gov |
| Secondary | EMOTICOM task battery | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | The EMOTICOM is a standardized test battery for social cognition. The following tests will be administered by the researchers: * Emotional recognition Task (Emotion Recognition/Categorization) * Face affective go no-go Task (Attentional Bias) * Social Information Preference Test (Theory of Mind) * Moral Emotions Task * Discounting Task (Delay and Probability Discounting) | ClinicalTrials.gov |
| Secondary | Aggressive behaviours | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | A virtual reality (VR) task will be used to measure aggressive behaviours. Participants will be asked to sit down comfortably and put on a VR headset with the help of a study member. They will be asked to choose an avatar and complete a scenario in a virtual environment. A study team member will guide them through the scenario. Four similar but distinct scenarios have been designed. Each scenario follows a standardized course. The scenarios aim to trigger irritation and anger. Aggressive behaviours will be assessed through observation of participants' behaviour during each scenario. Behaviours will be rated and categorised into three categories: 1) non-aggressive behaviour (e.g., prosocial and avoidance), 2) mild aggressive behaviour (e.g., coercion and verbal aggression); and 3) severe aggressive behaviour (e.g., physical aggression and destructive aggression). Two independent raters will rate each behaviour to achieve consensus. | ClinicalTrials.gov |
| Secondary | Brief Measure of Parental Wellbeing (BMPW) | At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44) | A self-reported instrument consisting of eight items and using a 10-point rating scale. A total wellbeing score was calculated by adding the scores allocated across the eight items with higher scores indicative of better wellbeing. | ClinicalTrials.gov |
| Other | Inventory of Callous-Unemotional Trait (ICU) | Baseline | A self-reported, 24-item questionnaire with 3 subscales: Callousness, Uncaring, and Unemotional. Items are scored on a 4-point Likert scale ranging from 0 (not at all true) to 3 (definitely true). | ClinicalTrials.gov |
| Other | Alabama Parenting Questionnaire (APQ) | Baseline | The APQ is a self-reported measure of several dimensions of parenting that have proven to be important for understanding the causes of conduct problems and delinquency in youth: Positive Reinforcement, Parental Involvement, Inconsistent Discipline, Poor Monitoring and Supervision, and Harsh Discipline. The Parent/Guardian and Child version will be administered. | ClinicalTrials.gov |
| Other | Autism-Spectrum Quotient (AQ) | Baseline | The AQ measures the degree to which a a person with normal intelligence has autistic traits. It comprises 50 questions, made up of 10 questions assessing 5 different areas: social skills, attention switching, attention to detail, communication, and imagination. For children (15 years-old and under), a parent/carer completes the questionnaire. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
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 | Source |
|---|---|---|
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Probability Discounting Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)