Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00676429
First received: May 9, 2008
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

To investigate and compare the efficacy, safety and tolerability of ziprasidone versus placebo in the treatment of conduct disorder (CD), oppositional defiant disorder (ODD) and disruptive behavior disorder not otherwise specified (DBD-NOS) of older children and adolescents in an outpatient setting.

Conduct and other behavior disorders are some of the most common forms of psychopathology in children and adolescents. The main characteristic of these disorders is a repetitive and persistent pattern of antisocial, aggressive or defiant behavior that involves major violations of age-appropriate expectations or norms. According to the guidelines of the German Society for Child & Adolescent Psychiatry & Psychotherapy (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und -psychotherapie DGKJPP), the European Society for Child and Adolescent Psychiatry (ESCAP), and the American Academy of Child and Adolescent Psychiatry (AACAP) currently no standard pharmacotherapy is established and recommended for children and adolescents. However Risperidone has been shown to be effective in the treatment of patients with disruptive behavior disorders and below average IQ.


Condition Intervention Phase
Conduct Disorder
Oppositional Defiant Disorder
Drug: Ziprasidone Hydrochloride
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders in Children and Adolescents - a Placebo Controlled, Randomized, Double Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales "Conduct Problem" and "Oppositional Behavior" [ Time Frame: Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the safety and tolerability by adverse event documentation. [ Time Frame: Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11) ] [ Designated as safety issue: Yes ]
  • Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I). [ Time Frame: Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11) ] [ Designated as safety issue: No ]
  • Correlation between dosage, efficacy and adverse events. [ Time Frame: Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11) ] [ Designated as safety issue: Yes ]
  • Ziprasidone serum levels [ Time Frame: Visit 5 (week 3) and Visit 8 (week 8) ] [ Designated as safety issue: Yes ]
  • Correlation between serum level, efficacy and adverse events [ Time Frame: Visit 5 (week 3) and Visit 8 (week 8) ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ziprasidone Hydrochloride oral solution with individual titration from 5 mg to 40 mg per day
Drug: Ziprasidone Hydrochloride
Ziprasidone Hydrochloride oral solution, individual titration 5 mg o.d. or 10 mg to 40 mg b.i.d
Other Name: Zeldox 10mg/ml Suspension zum Einnehmen
Placebo Comparator: 2
Placebo oral solution
Drug: Placebo
Placebo as oral solution, individually titrated
Other Name: Placebo Suspension zum Einnehmen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
  • The subject (male or female) must be between 7-17 (inclusive) years of age at screening.
  • The subject must have a primary diagnosis of Conduct Disorder [CD] (312.8), Oppositional Defiant Disorder [ODD] (313.81) or Disruptive Behavior Disorder not otherwise specified [DBD-NOS] (312.9) as defined by DSM-IV criteria and confirmed by the Kiddie-SADS-PL.
  • At the screening visit (Visit 1), subjects must have a score of 21 or more on the sum of the scales for conduct problems and for oppositional behaviour in the NCBRF-TIQ.
  • In the investigator's opinion, the subject must be likely to benefit from the therapy.
  • The subject is willing and able to discontinue any medications that are prohibited in this study (see Concomitant Medications table, Section 3.5.1). Any such medications must be discontinued at least 5 half-lives prior to the administration of double-blinded study medication.
  • Patients who are receiving prohibited medications are to be considered for the protocol only If discontinuation of the medication does not compromise the welfare of the patient and/or alternative medication that is allowed by the protocol is available and appropriate for the patient. Psychotropic medications should be tapered down per accepted medical practice and the specific package insert instead of being abruptly discontinued.
  • Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:

    • Are instructed and agree to avoid pregnancy during the study.
    • Have a negative pregnancy test (β-HCG) at screening and Visit 2.
    • Use one of the following birth control methods:

      • an oral contraceptive agent, an intrauterine device (ILTD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g. Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or
      • a barrier method of contraception, e.g., condom and / or diaphragm with spermicide while participating in the study.
      • abstinence for at least 3 months before the start of the study and intention to abstain from sexual activity during the study period.
  • Subjects must have an IQ > 55 best tested with the HAWIK-III, alternatively with the CFT-20 or K-ABC.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676429

Locations
Germany
University Hospital Freiburg, Dep. for Child & Adolescent Psychiatry
Freiburg, Germany, D-79104
Sponsors and Collaborators
University Hospital Freiburg
Pfizer
Investigators
Principal Investigator: Eberhard Schulz, MD University Hospital Freiburg, Dep. for Child & Adolescent Psychiatry
Study Chair: Christian Fleischhaker, MD University-Hospital Freiburg, Dep. for Child & Adolescent Psychiatry
Study Director: Klaus Hennighausen, MD University Hospital Freiburg
  More Information

No publications provided

Responsible Party: Professor Dr. Eberhard Schulz, MD, University Hospital Freiburg, Dept. of Child & Adolescent Psychiatry
ClinicalTrials.gov Identifier: NCT00676429     History of Changes
Other Study ID Numbers: NRA1280023, EudraCT: 2006-002207-13
Study First Received: May 9, 2008
Last Updated: November 17, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
European Union: European Medicines Agency

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Mental Disorders Diagnosed in Childhood
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014