An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior

Condition(s) targeted: Attention-Deficit/Hyperactivity Disorder, Combined Type; Disruptive Behavior Disorder

Intervention: Quetiapine, Oros methylphenidate (Drug)

Phase: Phase 2

Status: No longer recruiting

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
David W Dunn, MD, Principal Investigator, Affiliation: Indiana University School of Medicine

The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.

Official title: An Open-Label Pilot Study of Quetiapine Addition to Oros Methylphenidate in the Treatment of ADHD and High-Aggression Disruptive Behavior Disorders

Study design: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Rating of Aggression Against People and/or Property Scale (RAAPP) Rating Score

Secondary outcome:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (Investigator Administered and Scored) (ADHDRS-IV-Parent:Inv) Total Score

Conners’ Continuous Performance Test (CCPT) Index Score

SNAP-IV Inattention and Hyperactivity-Impulsivity Subscale Scores

Modified Overt Aggression Scale (MOAS)

Clinical Global Impressions-Severity (CGI-S)

Clinical Global Impressions-Improvement (CGI-I)

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must meet DSM-IV criteria for ADHD/Combined Type and one of the Disruptive Behavior Disorders

- Subjects must have one DSM-IV aggressive feature of Conduct Disorder

- Subjects with previous trials of psychostimulants must have had a response insufficient to markedly change overall quality of life

- Subjects must not have taken any medication for the treatment of ADHD or DBD for either 5 half-lives of the medication or 28 days (whichever is less) at Visit

- Laboratory results obtained at Visit 1 must be reviewed by a physician by Visit 2 and show no significant abnormalities

- Baseline electrocardiogram (ECG) results obtained at Visit 1 must be assessed by a physician by Visit 2 and show no significant abnormalities.

Exclusion Criteria:

- Subjects with likely mental retardation as defined as a K-BIT Matrices IQ score of less than 70 at Visit 1.

- Subjects who meet criteria for bipolar disorder as diagnosed by clinical interview and confirmed by the K-SADS-PL at Visit 1.

- Subjects with a biological parent or sibling who meets criteria for bipolar disorder

- Subjects who have any history of psychosis

- Subjects who weigh less than 30kg or more than 80kg at study entry

- Female subjects who are pregnant or who are breast-feeding

Riley Hospital, Riley Child and Adolescent Psychiatry Clinic, Indianapolis, Indiana 46202-5200, United States

Starting date: September 2003
Last updated: September 13, 2005