Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2014-11-19
2017-08-12
Brief Summary
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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
Detailed Description
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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 and burden on both the patients and their family. Although methylphenidate (MPH) showed good efficacy in the treatment of ADHD, there is still lack of well-established pharmacological treatment for DMDD. Furthermore, little research focuses on the effect of pharmacological treatment on neural correlates of chronic irritability. Previous literature suggested the potential role of atypical antipsychotics in the treatment of DMDD. Therefore, this study aimed to investigate the effectiveness of adjuvant of aripiprazole (APZ) to MPH in patients with comorbid ADHD and DMDD. In addition, the investigators explored the clinical manifestation and neural basis of DMDD using inventories, neuropsychological tests and neuroimaging studies.
Methods:
The investigators enrolled patients with ADHD+DMDD (n = 31) and ADHD only (n = 27). Those subjects were evaluated with inventories of emotional and behavioral problems, neuropsychological tests, as well as fMRI with challenging tests which aimed to induce frustration at baseline assessment. Then, subjects of ADHD+DMDD group received 6 weeks' combination treatment of MPH+ APZ with flexible dosage according to clinical judgment. All the initial evaluations were administered again after treatment. The comparison of clinical characteristics and neuroimaging findings between ADHD+DMDD group and ADHD only group will be conducted. In addition, the effectiveness of treatment will be analyzed. The effects of pharmacological treatment on neural correlates of chronic irritability will also be investigated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADHD+DMDD Group
The subjects with comorbid ADHD and DMDD received pharmacological intervention with combination treatment of MPH+ APZ with flexible dosage according to clinical judgment for six weeks.
MPH + APZ
MPH was administered with either Ritalin (from 10mg/day to 40mg/day) or Concerta (from 18mg/day to 36mg/day) according to clinical judgement for six weeks. APZ was administered with dose from 2.5mg/day to 5mg/day according to clinical judgement for six weeks.
Interventions
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MPH + APZ
MPH was administered with either Ritalin (from 10mg/day to 40mg/day) or Concerta (from 18mg/day to 36mg/day) according to clinical judgement for six weeks. APZ was administered with dose from 2.5mg/day to 5mg/day according to clinical judgement for six weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
17 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Tri-Service General Hospital
OTHER
Responsible Party
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Chin-Bin Yeh, MD, PhD
Director of Department of Psychiatry
Principal Investigators
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Chin-Bin Yeh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tri-Service General Hospital, National Defense Medical Center
Other Identifiers
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TSGH 099-05-159
Identifier Type: -
Identifier Source: org_study_id