Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00034801

Collaborator

(none)

378

Enrollment

Locations

17.9

Duration (Months)

12.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a research study comparing the safety and efficacy of two active study medications

Condition or Disease	Intervention/Treatment	Phase
Depression Schizophrenia Schizoaffective Disorder	Drug: olanzapine Drug: ziprasidone	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression

Study Start Date :

Sep 1, 2001

Study Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects 18-60 years of age
Female subjects of childbearing potential must be using a medically accepted means of contraception
Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
Subjects must be considered reliable

Exclusion Criteria:

Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
Female subjects who are either pregnant or nursing
Uncorrected hypothyroidism or hyperthyroidism
Narrow-angle glaucoma

Contacts and Locations

Locations

	City	State	Country
1	Tuscaloosa	Alabama	United States
2	Little Rock	Arkansas	United States
3	Anaheim	California	United States
4	Chula Vista	California	United States
5	Lafayette	California	United States
6	Long Beach	California	United States
7	Orange	California	United States
8	Poway	California	United States
9	Rosemeade	California	United States
10	San Diego	California	United States
11	Denver	Colorado	United States
12	New Britain	Connecticut	United States
13	Winter Park	Florida	United States
14	Augusta	Georgia	United States
15	Prairie Village	Kansas	United States
16	Gaithersburg	Maryland	United States
17	Mt Pleasant	Michigan	United States
18	St Louis	Missouri	United States
19	Lincoln	Nebraska	United States
20	Clementon	New Jersey	United States
21	Buffalo	New York	United States
22	New York	New York	United States
23	Staten Island	New York	United States
24	Charlotte	North Carolina	United States
25	Philadelphia	Pennsylvania	United States
26	Sioux Falls	South Dakota	United States
27	Austin	Texas	United States
28	El Paso	Texas	United States
29	Houston	Texas	United States
30	Salt Lake City	Utah	United States