Clinical trial NCT00034801: Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia
Official title: A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Schizophrenia
Schizoaffective Disorder
Keywords: Depression
Comorbid Depression
Schizophrenia
Schizoaffective Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Lafayette
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Poway
country: United States
state: California
city: Rosemeade
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Winter Park
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Prairie Village
country: United States
state: Kansas
city: Gaithersburg
country: United States
state: Maryland
city: Mt Pleasant
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Clementon
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Austin
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: