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Completed

NCT Number: NCT03358277

Aripiprazole Added on for DMDD in Youths With ADHD

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

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Key information

Conditions

Disruptive Mood Dysregulation Disorder

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPH + APZ

Drug

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 names: MPH (Ritalin, Concerta), APZ (Abilify)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Conner's Continuous Performance Test

    Time frame: six weeks

    A task-based computerized assessment of attention problems and neurological functioning

  4. Children Color Trail Test (CCTT)

    Time frame: six weeks

    The CCTT assesses sustained attention, sequencing, and other executive functions.

  5. 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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD

Acronym: AAOFDIYWA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2017
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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