Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
47 centers in Europe.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a wash out period of at least 24 hours, patients were randomized to ziprasidone or olanzapine.

Reporting Groups

	Description
Ziprasidone	Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
Olanzapine	Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.

Participant Flow:   Overall Study

	Ziprasidone	Olanzapine
STARTED	15 [1]	14 [1]
COMPLETED	5	2
NOT COMPLETED	10	12
Adverse Event	2	2
Lack of Efficacy	3	3
Withdrawal by Subject	0	2
symptomatic deterioration	1	1
Subject no longer willing to participate	2	2
study terminated by sponsor	1	0
withdrew patient after SAE resolved	1	0
Protocol Violation	0	2

Reporting Groups

	Description
Ziprasidone	Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
Olanzapine	Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.

Baseline Measures

	Ziprasidone	Olanzapine	Total
Number of Participants   [units: participants]	15	14	29
Age, Customized   [units: participants]
18-44 years	9	7	16
45-64 years	6	7	13
Gender   [units: participants]
Female	10	5	15
Male	5	9	14

1.  Primary:

Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.   [ Time Frame: 4 weeks ]

2.  Secondary:

Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.   [ Time Frame: up to 10 weeks ]

3.  Secondary:

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.   [ Time Frame: 6 months ]

4.  Secondary:

Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.   [ Time Frame: 4, 6 and 10 weeks ]

5.  Secondary:

Time to Symptomatic Remission in the Double Blind Phase.   [ Time Frame: up to 10 weeks ]

6.  Secondary:

Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.   [ Time Frame: 6 weeks ]

7.  Secondary:

Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.   [ Time Frame: 6 months ]