Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

NCT ID: NCT00145496

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-12-31

Brief Summary

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.

Conditions

Schizophrenia

Study Design

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

Study Groups

asenapine

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

5-10 mg sublingually twice daily for up to 26 weeks

olanzapine

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

5-20 mg by mouth once daily for up to 26 weeks

Interventions

Asenapine

5-10 mg sublingually twice daily for up to 26 weeks

Intervention Type: DRUG

Olanzapine

5-20 mg by mouth once daily for up to 26 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
• No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
• Caregiver required.

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

Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.

Reference Type: RESULT

PMID: 22198451 (View on PubMed)

Other Identifiers

Aphrodite

Identifier Type: -

Identifier Source: secondary_id

A7501013

Identifier Type: -

Identifier Source: secondary_id

P05771

Identifier Type: -

Identifier Source: org_study_id