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

November 30, 2017 updated by: Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • MPH (Ritalin, Concerta), APZ (Abilify)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
six weeks
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.
six weeks
Conner's Continuous Performance Test
Time Frame: six weeks
A task-based computerized assessment of attention problems and neurological functioning
six weeks
Children Color Trail Test (CCTT)
Time Frame: six weeks
The CCTT assesses sustained attention, sequencing, and other executive functions.
six weeks
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.
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tri-Service General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital, National Defense Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSGH 099-05-159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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