NCT00228046

Brief Summary

This study will assess whether adding a mood stabilizer, divalproex sodium, to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder (ADHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

3.5 years

First QC Date

September 26, 2005

Last Update Submit

October 29, 2013

Conditions

Attention Deficit Disorder With HyperactivityConduct DisorderOppositional Defiant Disorder

Keywords

ADHDODDConduct DisorderCD

Outcome Measures

Primary Outcomes (2)

  • Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment)

  • Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)

Interventions

Divalproex SodiumDRUG
MethylphenidateDRUG
DextroamphetamineDRUG
Mixed Amphetamine SaltsDRUG
Family CounselingBEHAVIORAL
Behavior Management Training with ParentsBEHAVIORAL

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of ADHD
  • Diagnosis of opposition defiant disorder or conduct disorder
  • Score that exceeds the study threshhold on the standardized scale of aggressive behavior

You may not qualify if:

  • Current psychosis
  • Current major depression
  • Current pervasive developmental disorder
  • Current obsessive compulsive disorder
  • Any other anxiety disorder as primary diagnosis
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Island Jewish Medical Center / Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794-8790, United States

Location

Related Publications (3)

  • Blader JC, Pliszka SR, Kafantaris V, Sauder C, Posner J, Foley CA, Carlson GA, Crowell JA, Margulies DM. Prevalence and Treatment Outcomes of Persistent Negative Mood Among Children with Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior. J Child Adolesc Psychopharmacol. 2016 Mar;26(2):164-73. doi: 10.1089/cap.2015.0112. Epub 2016 Jan 8.

    PMID: 26745211DERIVED

  • Blader JC, Pliszka SR, Kafantaris V, Foley CA, Crowell JA, Carlson GA, Sauder CL, Margulies DM, Sinha C, Sverd J, Matthews TL, Bailey BY, Daviss WB. Callous-unemotional traits, proactive aggression, and treatment outcomes of aggressive children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1281-93. doi: 10.1016/j.jaac.2013.08.024. Epub 2013 Sep 25.

    PMID: 24290461DERIVED

  • Blader JC, Schooler NR, Jensen PS, Pliszka SR, Kafantaris V. Adjunctive divalproex versus placebo for children with ADHD and aggression refractory to stimulant monotherapy. Am J Psychiatry. 2009 Dec;166(12):1392-401. doi: 10.1176/appi.ajp.2009.09020233. Epub 2009 Nov 2.

    PMID: 19884222DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityConduct DisorderOppositional Defiant Disorder

Interventions

Valproic AcidMethylphenidateDextroamphetamineFamily Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsPhenylacetatesAcids, CarbocyclicPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesPsychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joseph C. Blader, PhD, MSc

    Stony Brook State University of New York School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

January 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

US(2)