Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Viatris

Status and phase: Withdrawn; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: ziprasidone oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01124877

A1281197

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects must have received study medication in Study A1281196.
• In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.

Exclusion criteria

• Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
• Subjects who are judged by the investigator as being at imminent risk of suicide.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Open

Other group

Treatment:

Drug: ziprasidone oral capsules