Quetiapine and Concerta

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00550147
First received: October 25, 2007
Last updated: October 26, 2007
Last verified: October 2007

October 25, 2007
October 26, 2007
February 2004
Not Provided
CGIS severity, RAAPP, ADHD RS [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00550147 on ClinicalTrials.gov Archive Site
CPT, SNAP, MOAS,CGII [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Quetiapine and Concerta
An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Drug: Oros Methylphenidate

    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.
  • Drug: quetiapine

    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 6 7 8 9 25mg BID 50mg BID 100mg BID 200mg BID 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.

Experimental: 1
Oris Methylphenidate and Quetiapine
Interventions:
  • Drug: Oros Methylphenidate
  • Drug: quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2005
Not Provided

Inclusion Criteria:

  1. Subjects must be at least 12 years of age but less than 18 when informed consent is obtained.
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Laboratory results obtained at Visit 1 must be reviewed by a physician by Visit 2 and show no significant abnormalities.
  9. Baseline electrocardiogram (ECG) results obtained at Visit 1 must be assessed by a physician by Visit 2 and show no significant abnormalities.

Exclusion Criteria:

  1. Subjects with likely mental retardation as defined as a K-BIT Matrices IQ score of less than 70 at Visit 1.
  2. Subjects who meet criteria for bipolar disorder as diagnosed by clinical interview and confirmed by the K-SADS-PL at Visit 1.
  3. Subjects with a biological parent or sibling who meets criteria for bipolar disorder.
  4. Subjects who have any history of psychosis.
  5. Subjects who weigh less than 30kg or more than 80kg at study entry.
  6. 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.

  7. Subjects with a history of any seizure disorder other than febrile seizures.
  8. 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.
  9. 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.
  10. Subjects considered to be at serious suicidal risk.
  11. 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.
    • Drugs that may be used episodically during the trial include nonnarcotic analgesics, antacids, nonsteroidal anti-inflammatory drugs, antiasthma agents except steroids, antibiotics, antidiarrheal preparations, antiemetics, antihistamines, antihypertensives, nonsympathomimetic cold and cough preparations, cromolyn sodium, diphenhydramine, diuretics, hormones, insulin, laxatives, and oral hypoglycemic agents.
    • Drugs that may be used chronically during the trial include analgesics, nonsteroidal anti-inflammatory agents, antiasthma agents except steroids, antibiotics, nonsympathomimetic antihistamines, antihypertensives, cromolyn sodium, diuretics, hormones, insulin, laxatives, and oral hypoglycemic agents.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00550147
NCT00198211
Not Provided
Not Provided
Indiana University School of Medicine
Not Provided
Principal Investigator: David Dunn, MD Indiana University
Indiana University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP