Conduct DisorderPhase 2LiFT-CDNCT07923617
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
A Phase 2 study testing Lidexamfetamine in people with Conduct Disorder, run by Orygen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Conduct Disorder
- What is being tested?
- Lidexamfetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 10-15 years old (inclusive);
- Have a current diagnosis of DSM-5 conduct disorder, assessed with the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime version (K-SADS-PL);
- Are prescription stimulant-naïve, verified by the study doctor via SafeScript;
- Are seeking mental healthcare; and
- Can provide informed consent (sufficient English and adequate reading comprehension assessed; all participants will provide consent as will a carer or guardian).
Who cannot join
- Current or planned participation in another interventional study that would interfere with study participation in the opinion of the PI;
- Prior recreational use of stimulants (e.g., MDMA, amphetamines) assessed with the ASSIST-Y and corroborated by urine toxicology and study doctor during medical examination;
- Unstable medical conditions or contraindications for lisdexamfetamine including advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, phaeochromocytoma, tics and Tourette's syndrome, and history of seizures, assessed with medical exam, electrocardiogram, and clinical blood tests, and as assessed by the study doctor;
- Current treatment with contraindicated psychotropic medications that cannot be safely discontinued as determined by the study doctor, including monoamine oxidase inhibitors;
- Current or past DSM-5 psychotic or bipolar illness assessed with the K-SADS-PL;
- Current DSM-5 stimulant use disorder, moderate or severe, assessed with the K-SADS-PL;
- Acute suicidality or severe disturbance likely to interfere with the ability to comply with the study protocol as assessed by the study doctor with the C-SSRS;
- Pregnancy, breast feeding or, if sexually active and of child-bearing capacity, no effective contraception as assessed by study doctor during the medical examination and corroborated by clinical blood tests (hCG).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sarah T Clarke, BSc(Hons) contact
About this study
Official title: Lisdexamfetamine For the Treatment of Conduct Disorder in Children: A Randomized Crossover Trial
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.
Read the detailed description
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.
- Conditions
- Conduct Disorder
- Being tested
- Lidexamfetamine
- Keywords
- conduct disorder, lisdexamfetamine, aggression, social cognition, conduct problems
- Medical subject headings
- Conduct Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidexamfetamineDrug
In this study, two doses of lisdexamfetamine (30 mg and 60 mg) are tested
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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 Receives: Drug: Lidexamfetamine |
| Group B | Experimental | 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 Receives: Drug: Lidexamfetamine |
| Group C | Experimental | 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 Receives: Drug: Lidexamfetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Secondary outcomes (9)
Adverse events
All adverse events that arise during the study will be collected
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orygen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Alexandre A Guerin, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923617
- Sponsor's protocol ID
- ORY-P09-25-03
- Acronym
- LiFT-CD
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lisdexamfetamine For the Treatment of Conduct Disorder in Children: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07923617
- Acronym / sponsor ID
- LiFT-CD / ORY-P09-25-03
- Conditions
- Conduct Disorder
- Keywords
- conduct disorder, lisdexamfetamine, aggression, social cognition, conduct problems
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OrygenUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- Feb 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: LidexamfetamineIn 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 |
| Group B | Experimental | Drug: LidexamfetamineIn 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 |
| Group C | Experimental | Drug: LidexamfetamineIn 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 |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 10-15 years old (inclusive);
- Have a current diagnosis of DSM-5 conduct disorder, assessed with the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime version (K-SADS-PL);
- Are prescription stimulant-naïve, verified by the study doctor via SafeScript;
- Are seeking mental healthcare; and
- Can provide informed consent (sufficient English and adequate reading comprehension assessed; all participants will provide consent as will a carer or guardian).
Key exclusion criteria (8 listed)
- Current or planned participation in another interventional study that would interfere with study participation in the opinion of the PI;
- Prior recreational use of stimulants (e.g., MDMA, amphetamines) assessed with the ASSIST-Y and corroborated by urine toxicology and study doctor during medical examination;
- Unstable medical conditions or contraindications for lisdexamfetamine including advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, phaeochromocytoma, tics and Tourette's syndrome, and history of seizures, assessed with medical exam, electrocardiogram, and clinical blood tests, and as assessed by the study doctor;
- Current treatment with contraindicated psychotropic medications that cannot be safely discontinued as determined by the study doctor, including monoamine oxidase inhibitors;
- Current or past DSM-5 psychotic or bipolar illness assessed with the K-SADS-PL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidexamfetamineIn this study, two doses of lisdexamfetamine (30 mg and 60 mg) are tested | Drug | Group A, Group B, Group C |
Primary outcome
Nisonger Child Behavior Rating Form - Conduct Problem scale
Time frame: 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.
9 secondary outcomes
Adverse events
Time frame: From enrollment to the end of study at Day 51
Columbia Suicide Severity Rating Scale (C-SSRS)
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)
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)
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)
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
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
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Aggressive behaviours
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)
Time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah T Clarke, BSc(Hons) contact
Alexandre A Guerin, PhD principal investigator
University of Melbourne
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidexamfetamine in people with Conduct Disorder, run by Orygen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre A Guerin, PhD (+61 406 310 861, alexandre.guerin@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nisonger Child Behavior Rating Form - Conduct Problem scale (time frame: At baseline and at Research Assessment 1 (Day 10), Research Assessment 2 (Day 27), and Research Assessment 3 (Day 44)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.