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Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

NCT00212771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2022-02-16

No results posted yet for this study

Summary

The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment.

Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.

Conditions

Interventions

DRUG

asenapine

Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.

DRUG

olanzapine

Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-09-30
Completion
2006-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00212771 on ClinicalTrials.gov