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

Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control


Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief 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.

Overall Status Completed
Start Date September 2004
Completion Date October 2006
Primary Completion Date September 2006
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in total PANSS score at endpoint Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint
Secondary Outcome
Measure Time Frame
Changes in PANSS subscale scores and Marder factor scores Every 24 weeks after baseline
Changes in CGI-S Every 12 weeks after baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) Every 48 weeks after baseline
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) Every 24 weeks after baseline
Resource utilization (as measured by frequency and length of hospital stay) During the entire study period
Safety and tolerability: EPS (AIMS, BARS, SARS) Every 24 weeks after baseline
Adverse Events Continuously and up to 7 days after endpoint
Pregnancy Test At endpoint
Blood Tests Every 12 weeks after baseline
Weight and vital signs Every 4 weeks after baseline
ECGs Every 24 weeks after baseline
Enrollment 440

Intervention Type: Drug

Intervention Name: asenapine

Description: 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 Group Label: Arm 1

Intervention Type: Drug

Intervention Name: olanzapine

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

Arm Group Label: Arm 2

Other Name: Zyprexa



Inclusion Criteria:

- Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

Exclusion Criteria:

- Have an uncontrolled, unstable, clinically significant medical condition.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

December 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1

Type: Experimental

Label: Arm 2

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov