Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

NCT ID: NCT00212784

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-04
• Study Completion Date: 2006-03-15

Brief Summary

The primary features of schizophrenia and schizoaffective disorder are characterized by 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 or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

asenapine

Intervention Type: DRUG

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.

Arm 2

Group Type: ACTIVE_COMPARATOR

olanzapine

Intervention Type: DRUG

Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

Interventions

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.

Intervention Type: DRUG

olanzapine

Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

Intervention Type: DRUG

Other Intervention Names

Org 5222; SCH 900274

Eligibility Criteria

Inclusion Criteria

• Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.

Exclusion Criteria

• Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.

Reference Type: RESULT

PMID: 20205074 (View on PubMed)

Other Identifiers

ACTAMESA, 25517

Identifier Type: -

Identifier Source: secondary_id

P05935

Identifier Type: -

Identifier Source: org_study_id