Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.

NCT00550147 | Completed Phase 2 Results DMC

• 1 other identifier: 0307-31 (IRB#)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD-Combined TypeDisruptive behavior Disorder

Outcome Measures

Primary Outcomes (1)

• RAAPP: Rating of Aggression Against People and/or Property Scale

  The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).

  See Arm/Group - Repeated Measures

Secondary Outcomes (4)

• CGI-S: Clinical Global Improvement Scale

  See Arm/Group - Repeated Measures

• Modified Overt Aggression Scale (MOAS)

  See arm/group - repeated measures

• Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale

  See arm/group - repeated measures analysis

• Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)

  See Arm/Group - repeated measures

Study Arms (1)

1

EXPERIMENTAL

Oros Methylphenidate and Quetiapine

Drug: Oros Methylphenidate; Drug: quetiapine

Interventions

Oros Methylphenidate DRUG

Oros methylphenidate will be titrated over 3 visits according to the following schedule: * Visit 2 dose of 18 mg QAM * Visit 3 dose of 36mg QAM * Visit 4 dose of 54mg QAM.

Also known as: Concerta

1

quetiapine DRUG

Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1). Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg) * Visit 5 dose of 25mg BID * Visit 6 dose of 50mg BID * Visit 7 dose of 100mg BID * Visit 8 dose of 200mg BID * Visit 9 dose of 300mg BID Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule.

Also known as: Seroquel

1

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must be at least 12 yrs.old but less than 18 when informed consent is obtained.
• Subjects must meet DSM-IV criteria for ADHD/Combined Type and one of the Disruptive Behavior Disorders as diagnosed by clinical interview and confirmed by the Kiddie-SADS-PL (K-SADS-PL) semistructured diagnostic interview.
• Subjects must have one DSM-IV aggressive feature of Conduct Disorder (CD) as rated on the K-SADS-PL including:
• initiation of physical fights (CD symptom A2)
• use of a weapon to bring harm to others (CD symptom A3)
• physical cruelty to people (CD symptom A4) or animals (CD symptom A5)
• confrontation stealing (CD symptom A6)
• destruction of property (CD symptom A8 or A9).
• Subjects must have severe aggressive and ADHD symptoms as indicated by a global CGI score of 4 or greater and a RAAPP score of 4 or 5 at Visit 1.
• Subjects must have had at least four outbursts per month involving destruction of property, verbal aggression, or physical aggression toward others or self during the past two months at Visit 1.
• Subjects with previous trials of psychostimulants must have had a response insufficient to markedly change overall quality of life as defined by a CGI score of 3 or greater based on interview with the parent.
• 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 1. If subjects are currently taking medications for the treatment of ADHD or DBD, the assent and consent must be reviewed and signed by the subject and parent/legal guardians (Visit 0) before the physician investigator will provide a tapering schedule for current medications.
• 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.

You may not qualify if:

• 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 as assessed at Visit 1.
• Postmenarcheal sexually-active females who are not using a clinically acceptable method of birth control.
• Subjects with a history of any seizure disorder other than febrile seizures.
• Subjects with a history of alcohol or drug abuse within the past three months or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medications in a manner considered abusive by the investigators.
• Subjects currently taking any psychotropic medications or who are likely to need psychotropic medications during the study as assessed by the physician at Visit 1.
• Subjects considered to be at serious suicidal risk.
• Subjects taking any medications that are not reviewed and approved by a physician investigator. Specific requirements include:
• Psychotropic medications other than quetiapine and Concerta may not be used during the trial.
• Patients may receive lorazepam or chlorpromazine if needed for severe aggression. These drugs should not be given beyond 24 hours.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Riley Childrens Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

There were no unanticipated limitations/caveats. All of the typical caveats of open-label studies apply: As a result, bias, placebo effects, demand characteristics, and other non-treatment related effects may have contributed to results.

Results Point of Contact

• Title: David W. Dunn, MD
• Organization: Indiana University School of Medicine

ddunn@iupui.edu

317-944-8162

Study Officials

• David Dunn, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 29, 2007
• Study Start: February 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 13, 2015
• Results First Posted: May 13, 2015

Record last verified: 2015-05

Locations

US (1)