To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

NCT ID: NCT00150176

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 831 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-07-31

Brief Summary

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Conditions

Schizophrenia

Study Design

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

Study Groups

asenapine

Group Type: EXPERIMENTAL

Asenapine - Open Label

Intervention Type: DRUG

Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).

Asenapine - Double Blind

Intervention Type: DRUG

Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.

placebo

Group Type: PLACEBO_COMPARATOR

Asenapine - Open Label

Intervention Type: DRUG

Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).

Placebo - Double Blind

Intervention Type: DRUG

Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.

Interventions

Asenapine - Open Label

Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).

Intervention Type: DRUG

Placebo - Double Blind

Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.

Intervention Type: DRUG

Asenapine - Double Blind

Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.

Intervention Type: DRUG

Other Intervention Names

Saphris, Org 5222, SCH 900274; Org 5222, SCH 900274, Saphris

Eligibility Criteria

Inclusion Criteria

• Have a primary diagnosis of schizophrenia
• History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
• History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
• Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Exclusion Criteria

• Have an uncontrolled, unstable clinically significant medical condition
• History of suicide attempt or significant violence to others in the past 2 years
• A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
• Current substance abuse/dependence
• Concurrent psychiatric disorder other than schizophrenia.

• 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

Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22.

Reference Type: DERIVED

PMID: 21367356 (View on PubMed)

Other Identifiers

A7501012

Identifier Type: -

Identifier Source: secondary_id

P05770

Identifier Type: -

Identifier Source: org_study_id