Disruptive Mood Dysregulation DisorderAAOFDIYWANCT03358277
Aripiprazole Added on for DMDD in Youths With ADHD
A study testing MPH + APZ in people with Disruptive Mood Dysregulation Disorder, run by Tri-Service General Hospital (TSGH).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Disruptive Mood Dysregulation Disorder
- What is being tested?
- MPH + APZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2014to 12 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD
Objectives:
- To investigate the effectiveness of adjuvant with aripiprazole to methylphenidate for disruptive mood dysregulation disorder (DMDD) in youths with attention-deficit/hyperactivity disorder (ADHD)
- To investigate the neural basis of chronic irritability in youths with functional magnetic resonance imaging (fMRI)
- To compare the clinical characteristics of youths with comorbid ADHD and DMDD to youths with ADHD only
Read the 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.
- Conditions
- Disruptive Mood Dysregulation Disorder
- Being tested
- MPH + APZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPH + APZDrug
Also called MPH (Ritalin, Concerta), APZ (Abilify)
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD+DMDD Group | Experimental | 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. Receives: Drug: MPH + APZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Behavior Checklist (CBCL) subscale scores
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.
Measured: six weeks
Secondary outcomes (5)
Swanson, Nolan, and Pelham Scale-version IV (SNAP-IV) total and subscale scores
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.
Measured: six weeks
Beck Youth Inventories-II subscale scores
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.
Measured: six weeks
Conner's Continuous Performance Test
A task-based computerized assessment of attention problems and neurological functioning
Measured: six weeks
Children Color Trail Test (CCTT)
The CCTT assesses sustained attention, sequencing, and other executive functions.
Measured: six weeks
Resting state functional magnetic resonance imaging
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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start19 Nov 2014
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Mood Dysregulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital (TSGH)
- Investigators
- Chin-Bin Yeh, MD, PhD, Principal investigator, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358277
- Sponsor's protocol ID
- TSGH 099-05-159
- Acronym
- AAOFDIYWA
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole Added on Methylphenidate in the Treatment of Youths With Comorbid ADHD and DMDD
- ClinicalTrials.gov ID
- NCT03358277
- Acronym / sponsor ID
- AAOFDIYWA / TSGH 099-05-159
- Conditions
- Disruptive Mood Dysregulation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To investigate the effectiveness of adjuvant with aripiprazole to methylphenidate for disruptive mood dysregulation disorder (DMDD) in youths with attention-deficit/hyperactivity disorder (ADHD)
- To investigate the neural basis of chronic irritability in youths with functional magnetic resonance imaging (fMRI)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD+DMDD Group | Experimental | Drug: MPH + APZThe 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject meets the DSM-5 criteria for ADHD and DMDD
- Subject is free from prior psychotropic medication for at least one year
- Subject meets the DSM-5 criteria for ADHD and DMDD
- Subject is free from prior psychotropic medication for at least one year
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPH + APZAlso: MPH (Ritalin, Concerta), APZ (Abilify)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. | Drug | ADHD+DMDD Group |
Primary outcome
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.
5 secondary outcomes
Swanson, Nolan, and Pelham Scale-version IV (SNAP-IV) total and subscale scores
Time frame: six weeks
Beck Youth Inventories-II subscale scores
Time frame: six weeks
Conner's Continuous Performance Test
Time frame: six weeks
Children Color Trail Test (CCTT)
Time frame: six weeks
Resting state functional magnetic resonance imaging
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Bin Yeh, MD, PhD principal investigator
Tri-Service General Hospital, National Defense Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing MPH + APZ in people with Disruptive Mood Dysregulation Disorder, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Behavior Checklist (CBCL) subscale scores (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.