Aripiprazole Added on for DMDD in Youths With ADHD (NCT03358277) | Clinical Trial Compass
CompletedNot Applicable
Aripiprazole Added on for DMDD in Youths With ADHD
58 participantsStarted 2014-11-19
Plain-language summary
Objectives:
1. To investigate the effectiveness of adjuvant with aripiprazole to methylphenidate for disruptive mood dysregulation disorder (DMDD) in youths with attention-deficit/hyperactivity disorder (ADHD)
2. To investigate the neural basis of chronic irritability in youths with functional magnetic resonance imaging (fMRI)
3. To compare the clinical characteristics of youths with comorbid ADHD and DMDD to youths with ADHD only
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For subjects with comorbid ADHD and DMDD:
* Subject meets the DSM-5 criteria for ADHD and DMDD
* Subject is free from prior psychotropic medication for at least one year
For subjects with ADHD only :
* Subject meets the DSM-5 criteria for ADHD and DMDD
* Subject is free from prior psychotropic medication for at least one year
Exclusion Criteria:
* Patients not willing to participate in the study after detailed explanation
* Patients who could not follow the investigator's instructions
* Patients with severe neurological or mental illness such as epileptic disorder, schizophrenia, bipolar disorder, mental retardation or uncontrolled suicide risk
* Patients with severe medical illness or surgical conditions which were judged by investigators for safety concerns as inappropriate for this study, such as uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension.
* Patients taking psychotropic medication within one year prior to the evaluation for entering our study
* Patients being allergic to methylphenidate or aripiprazole
* Female patients being pregnant, nursing, or lactating
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.