Ziprasidone And Olanzapine's Outcomes In Mania (ZOOM)

Viatris

Status and phase

Terminated

Phase 4

Conditions

Bipolar Disorder, Manic

Acute Mania

Treatments

Drug: olanzapine

Drug: ziprasidone hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00329108

A1281147

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.

Enrollment

29 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).

Exclusion criteria

Have a diagnosis of learning disability or organic brain syndrome.
Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.