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

Lilly

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder; Depression

Treatments: Drug: ziprasidone; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034801

5529

F1D-US-HGJU

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind