6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

Organon

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: olanzapine; Drug: asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265343

25544

Aphrodite

P05777

Details and patient eligibility

About

This is an extension study to further test

the efficacy and safety of asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

• Have demonstrated an acceptable

degree of compliance and completed the 25543

trial, and would benefit from continued treatment

according to the investigator.

Exclusion criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have been judged to be medically

noncompliant in the management of their disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

306 participants in 2 patient groups

1

Experimental group

Description:

asenapine

Treatment:

Drug: asenapine

2

Active Comparator group

Description:

olanzapine

Treatment:

Drug: olanzapine