NCT03358277

Brief Summary

Objectives:

  1. 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. 2.To investigate the neural basis of chronic irritability in youths with functional magnetic resonance imaging (fMRI)
  3. 3.To compare the clinical characteristics of youths with comorbid ADHD and DMDD to youths with ADHD only

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

November 24, 2017

Last Update Submit

November 30, 2017

Conditions

Disruptive Mood Dysregulation Disorder

Outcome Measures

Primary Outcomes (1)

  • 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(0-20), Rule-Breaking Behavior (0-34), Somatic Complaints (0-22), Social Problems (0-22), Thought Problems (0-30), and Withdrawn/Depressed (0-16).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.

    six weeks

Secondary Outcomes (5)

  • Swanson, Nolan, and Pelham Scale-version IV (SNAP-IV) total and subscale scores

    six weeks

  • Beck Youth Inventories-II subscale scores

    six weeks

  • Conner's Continuous Performance Test

    six weeks

  • Children Color Trail Test (CCTT)

    six weeks

  • Resting state functional magnetic resonance imaging

    six weeks

Study Arms (1)

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.

Drug: MPH + APZ

Interventions

MPH + APZDRUG

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.

Also known as: MPH (Ritalin, Concerta), APZ (Abilify)
ADHD+DMDD Group

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

5,10-dihydro-5-methylphenazineMethylphenidateAripiprazole

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chin-Bin Yeh, MD, PhD

    Tri-Service General Hospital, National Defense Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Psychiatry

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 30, 2017

Study Start

November 19, 2014

Primary Completion

August 12, 2017

Study Completion

August 12, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share