Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders

NCT00676429 | Completed Phase 2

• 2 other identifiers: NRA1280023EudraCT: 2006-002207-13
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales "Conduct Problem" and "Oppositional Behavior"

  Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11)

Secondary Outcomes (5)

• Assessment of the safety and tolerability by adverse event documentation.

  Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11)

• Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I).

  Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11)

• Correlation between dosage, efficacy and adverse events.

  Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11)

• Ziprasidone serum levels

  Visit 5 (week 3) and Visit 8 (week 8)

• Correlation between serum level, efficacy and adverse events

  Visit 5 (week 3) and Visit 8 (week 8)

Study Arms (2)

1

EXPERIMENTAL

Ziprasidone Hydrochloride oral solution with individual titration from 5 mg to 40 mg per day

Drug: Ziprasidone Hydrochloride

2

PLACEBO COMPARATOR

Placebo oral solution

Drug: Placebo

Interventions

Ziprasidone Hydrochloride DRUG

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

Also known as: Zeldox 10mg/ml Suspension zum Einnehmen

1

Placebo DRUG

Placebo as oral solution, individually titrated

Also known as: Placebo Suspension zum Einnehmen

2

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Pfizer: collaborator

Study Sites (1)

University Hospital Freiburg, Dep. for Child & Adolescent Psychiatry

Freiburg im Breisgau, D-79104, Germany

Location

MeSH Terms

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

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

Study Officials

• Eberhard Schulz, MD

  University Hospital Freiburg, Dep. for Child & Adolescent Psychiatry

  PRINCIPAL INVESTIGATOR

• Christian Fleischhaker, MD

  University-Hospital Freiburg, Dep. for Child & Adolescent Psychiatry

  STUDY CHAIR

• Klaus Hennighausen, MD

  University Hospital Freiburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 18, 2008

Record last verified: 2008-11

Locations

DE (1)