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 range7 Years – 17 Years
SexALL
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