Ziprasidone And Olanzapine's Outcomes In Mania

Phase 4

Terminated

• Conditions: Bipolar Disorder, Manic; Acute Mania
• Interventions: Drug: ziprasidone hydrochloride; Drug: olanzapine

• Registration Number: NCT00329108
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Study Start: 2006-11
• Primary Completion: 2007-07
• Study Completion: 2008-01
• Results First Submitted: 2008-12-22
• Results First Submitted QC: 2009-03-12
• Results First Posted: 2009-03-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ziprasidone hydrochloride	-
B	olanzapine	-

Primary Outcome Measures

Name	Time	Method
Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.	4 weeks	YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.	4, 6 and 10 weeks
Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.	up to 10 weeks
Time to Symptomatic Remission in the Double Blind Phase.	up to 10 weeks
Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.	6 months
Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.	6 weeks
Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.	6 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Istanbul, Turkey