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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

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

Condition or disease Intervention/treatment Phase
Disruptive Mood Dysregulation Disorder Drug: MPH + APZ Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD
Actual Study Start Date : November 19, 2014
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : August 12, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358277


Sponsors and Collaborators
Tri-Service General Hospital
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Chin-Bin Yeh, MD, PhD Tri-Service General Hospital, National Defense Medical Center

Responsible Party: Chin-Bin Yeh, MD, PhD, Director of Department of Psychiatry, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03358277     History of Changes
Other Study ID Numbers: TSGH 099-05-159
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aripiprazole
Methylphenidate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents