Clinical trial NCT03358277: Aripiprazole Added on for DMDD in Youths With ADHD
Official title: Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Mood Dysregulation Disorder
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-11-30
Enrollment: 58
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Behavior Checklist (CBCL) subscale scores
timeFrame: six weeks
Secondary outcomes:
measure: Swanson, Nolan, and Pelham Scale-version IV (SNAP-IV) total and subscale scores
timeFrame: six weeks
measure: Beck Youth Inventories-II subscale scores
timeFrame: six weeks
measure: Conner's Continuous Performance Test
timeFrame: six weeks
measure: Children Color Trail Test (CCTT)
timeFrame: six weeks
measure: Resting state functional magnetic resonance imaging
timeFrame: six weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center
name: Chin-Bin Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: