Status:
COMPLETED
Aripiprazole Added on for DMDD in Youths With ADHD
Lead Sponsor:
Tri-Service General Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Conditions:
Disruptive Mood Dysregulation Disorder
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief 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 disor...
Detailed Description
Background: Disruptive mood dysregulation disorder (DMDD) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) is a common clinical challenge and leads to severe impact an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03358277
Start Date
November 19 2014
End Date
August 12 2017
Last Update
December 2 2017
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