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Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders

NCT00676429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2008-11-18

No results posted yet for this study

Summary

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.

Conditions

  • Conduct Disorder
  • Oppositional Defiant Disorder

Interventions

DRUG

Ziprasidone Hydrochloride

Ziprasidone Hydrochloride oral solution, individual titration 5 mg o.d. or 10 mg to 40 mg b.i.d

DRUG

Placebo

Placebo as oral solution, individually titrated

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Eberhard Schulz, MD · University Hospital Freiburg, Dep. for Child & Adolescent Psychiatry

  • Christian Fleischhaker, MD · University-Hospital Freiburg, Dep. for Child & Adolescent Psychiatry

  • Klaus Hennighausen, MD · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676429 on ClinicalTrials.gov