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

NCT00150176 | Completed Phase 3 Results DMC

• 2 other identifiers: P05770A7501012
• Study Type: interventional
• Target: 831
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time to Relapse or an Impending Relapse

  A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

  time of first relapse up to Day 182 (double blind phase)

Secondary Outcomes (1)

• Time to Early Discontinuation for Any Reason

  time of discontinuation up to Day 182 (double blind phase)

Study Arms (2)

asenapine

EXPERIMENTAL

Drug: Asenapine - Open Label; Drug: Asenapine - Double Blind

placebo

PLACEBO COMPARATOR

Drug: Asenapine - Open Label; Drug: Placebo - Double Blind

Interventions

Asenapine - Open Label 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).

Also known as: Saphris, Org 5222, SCH 900274

asenapine; placebo

Placebo - Double Blind DRUG

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

placebo

Asenapine - Double Blind DRUG

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

Also known as: Org 5222, SCH 900274, Saphris

asenapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 21367356 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 8, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 8, 2022
• Results First Posted: May 28, 2010

Record last verified: 2022-02