A Phase 2 interventional study of Lidexamfetamine in Conduct Disorder, sponsored by Orygen. Not yet recruiting. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Orygen · Phase 2, Interventional, and Treatment
About 2 in every 100 Australian children have conduct disorder, a serious mental health condition characterised by antisocial behaviours like aggression and rule breaking. This condition leads to big problems not only for the children but also for their families. Despite its major impacts, conduct disorder is not well understood, and treatments are limited. Talk therapy works best, but it's hard to access and is expensive. Current medications can help but often cause unwanted side effects. Stimulant medications (like those used for Attention Deficit/Hyperactivity Disorder or ADHD) may help reduce aggression and impulsive behavior in children with conduct disorder. One medication called lisdexamfetamine shows promise. It is safe and already approved for treating ADHD in children in Australia, and only needs to be taken once a day. Because it's safe and already in use for similar conditions, it could be a promising option for treating conduct disorder in children. This study will test if lisdexamfetamine can reduce conduct disorder symptoms in children aged 10 to 15 years old compared to placebo.
Conduct disorder is a leading cause of disease and disability, yet there are few effective pharmacotherapies and none that treat the core symptoms of the disorder. There is an urgent need to investigate novel medications for conduct disorder in children. Lisdexamfetamine is a promising candidate that has the potential to target conduct problems and impulsive behaviour. It is also well characterised and safe for paediatric use, being TGA-approved for paediatric ADHD. This study is a prospective, within-subject, placebo-controlled, randomised cross-over experimental medicine study. All participants will receive lisdexamfetamine (30 mg), lisdexamfetamine (60 g), and placebo for 7 days, in a randomised order.
The primary objective of this study is to test in a double-blind, within-subject, placebo-controlled, randomized cross-over trial whether lisdexamfetamine dose-dependently reduces conduct disorder symptoms relative to placebo in children (10-15 years-old) with conduct disorder. We will compare carer-reported conduct disorder symptoms (the primary outcome) over 1-week of lisdexamfetamine treatment (30, 60 mg) compared to placebo in N = 30 children with conduct disorder.
The secondary objective is to assess the effects of lisdexamfetamine (30 mg, 60 mg) compared to placebo on safety, tolerability, problem behaviours, substance use, quality of life, ADHD symptoms, social cognition, aggressive behaviours, and carer well-being. Exploratory objectives are to assess potential mechanisms and predictor of treatment response, including callous and unemotional trait, parenting, and autism spectrum traits.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →Orygen is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, participants receive the following interventions in this order: 1. Placebo for 10 days 2. Placebo lead-in for 3 days, then Lisdexamfetamine (30 mg) for 7 days 3. Lisdexamfetamine (30 mg) lead-in for 3 days, then Lisdexamfetamine (60 mg) for 7 days
Drug: Lidexamfetamine
In this arm, participants receive the following interventions in this order: 1. Placebo lead-in for 3 days, then Lisdexamfetamine (30 mg) for 7 days 2. Lisdexamfetamine (30 mg) lead-in for 3 days, then Lisdexamfetamine (60 mg) for 7 days 3. Placebo for 10 days
Drug: Lidexamfetamine
In this arm, participants receive the following interventions in this order: 1. Placebo lead-in for 3 days, then Lisdexamfetamine (30 mg) for 7 days 2. Placebo for 10 days 3. Lisdexamfetamine (30 mg) lead-in for 3 days, then Lisdexamfetamine (60 mg) for 7 days
Drug: Lidexamfetamine
In this study, two doses of lisdexamfetamine (30 mg and 60 mg) are tested
Nisonger Child Behavior Rating Form - Conduct Problem scale
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.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Adverse events
All adverse events that arise during the study will be collected
Time frame: From enrollment to the end of study at Day 51
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: 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).
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)
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.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Timeline Follow Back (TLFB)
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).
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Assessment of Quality of Life - 6 Dimension - Adolescent (AQoL-6D-A)
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.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
SNAP-IV Teacher and Parent Rating Scale
The SNAP-IV is a self-reported tool to assess for ADHD symptoms. Parents or guardians of participants will complete it.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
EMOTICOM task battery
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)
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Aggressive behaviours
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.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Brief Measure of Parental Wellbeing (BMPW)
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.
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Inventory of Callous-Unemotional Trait (ICU)
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).
Time frame: Baseline
Alabama Parenting Questionnaire (APQ)
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.
Time frame: Baseline
Autism-Spectrum Quotient (AQ)
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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: Starting 6 months after publication of primary outcome
Access criteria: Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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