Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Not Applicable

• Conditions: Schizophrenia, unspecified; -F209 Schizophrenia, unspecified; F209

• Registration Number: PER-103-06
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. The subject and the authorized legal representative must understand the nature of the study and must be able to obey the protocol requirements. The representative must sign an Informed Consent Document and the subject must provide the Written Consent.
2. Subjects must have received the study medication in study A1281134.
3. In the opinion of the investigator, the subject should be likely to benefit from antipsychotic therapy and should not represent any concern about clinically significant safety during the preceding double-blind study.
4. Women with potential for maternity may be included, provided they are not pregnant, or breastfeeding, and are practicing effective contraception.

Exclusion Criteria

1. The subjects who experienced a serious adverse event.
2. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation during the preceding study.
3. Subjects that require some medication not allowed.
4. Subjects that require treatment with drugs that are known to prolong QT consistently.
5. Subjects with a grade of 7 in the individual section of Suicidal Idea of the CDRS-R.
6. Subjects who may be at imminent risk of suicide
during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified