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Aripiprazole Added on for DMDD in Youths With ADHD (AAOFDIYWA)

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ClinicalTrials.gov Identifier: NCT03358277
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital

November 24, 2017
November 30, 2017
December 2, 2017
November 19, 2014
August 12, 2017   (Final data collection date for primary outcome measure)
Child Behavior Checklist (CBCL) subscale scores [ Time Frame: six weeks ]
The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The patient is rated on 113 items scored on a 3-point Likert-type scale. CBCL consists of eight empirically-based syndrome subscales. The range of subscale scores (summed) are: Aggressive Behavior (0-36), Anxious/Depressed (0-26), Attention Problems (0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16). The higher score suggests the more severe symptoms.
Child Behavior Checklist (CBCL) total and subscale scores [ Time Frame: six weeks ]
The Child Behavior Checklist (CBCL) is a widely used caregiver report form identifying problem behavior in children. The eight empirically-based syndrome scales are: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems, and Withdrawn/Depressed.
Complete list of historical versions of study NCT03358277 on ClinicalTrials.gov Archive Site
  • Swanson, Nolan, and Pelham Scale—version IV (SNAP-IV) total and subscale scores [ Time Frame: six weeks ]
    The SNAP-IV is a widely used caregiver report form identifying Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children. The patient is rated on 26 items scored on a 4-point Likert-type scale. SNAP-IV consists of three subscales: inattention (items #1-#9, range of subscale summed score 0-27), hyperactivity/ impulsivity (items #11-#18, range of subscale summed score 0-27), and symptoms of Oppositional Defiant Disorder (items #19-#26, range of subscale summed score 0-24). The higher score suggests the more severe symptoms.
  • Beck Youth Inventories-II subscale scores [ Time Frame: six weeks ]
    An self-reported inventory to evaluate children's and adolescents' emotional and social impairment. It includes five subscales: depression, anxiety, anger, disruptive behaviour, and self-concept. Each subscale consists of 20 items, and each item is scored on a 4-point Likert-type scale. The range of each subscale scores (summed) is 0-60. The higher score suggests the more severe symptoms.
  • Conner's Continuous Performance Test [ Time Frame: six weeks ]
    A task-based computerized assessment of attention problems and neurological functioning
  • Children Color Trail Test (CCTT) [ Time Frame: six weeks ]
    The CCTT assesses sustained attention, sequencing, and other executive functions.
  • Resting state functional magnetic resonance imaging [ Time Frame: six weeks ]
    A method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task.
  • Beck Youth Inventories-II total and subscale scores [ Time Frame: six weeks ]
    An self-reported inventory to evaluate children's and adolescents' emotional and social impairment. It includes five subscales: depression, anxiety, anger, disruptive behaviour, and self-concept.
  • Conner's Continuous Performance Test [ Time Frame: six weeks ]
    A task-based computerized assessment of attention problems and neurological functioning
  • Children Color Trail Test (CCTT) [ Time Frame: six weeks ]
    The CCTT assesses sustained attention, sequencing, and other executive functions.
  • Resting state functional magnetic resonance imaging [ Time Frame: six weeks ]
    A method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task.
  • Swanson, Nolan, and Pelham Scale—version IV (SNAP-IV) total and subscale scores [ Time Frame: six weeks ]
    The items from the DSM-IV (1994) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/ impulsivity (items #11-#19). Also, items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28) since it often is present in children with ADHD.
Not Provided
Not Provided
 
Aripiprazole Added on for DMDD in Youths With ADHD
Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD

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

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Disruptive Mood Dysregulation Disorder
Drug: 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 Name: MPH (Ritalin, Concerta), APZ (Abilify)
Experimental: 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.
Intervention: Drug: MPH + APZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
Same as current
August 12, 2017
August 12, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03358277
TSGH 099-05-159
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital
Tri-Service General Hospital
Ministry of Science and Technology, Taiwan
Principal Investigator: Chin-Bin Yeh, MD, PhD Tri-Service General Hospital, National Defense Medical Center
Tri-Service General Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP