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

February 7, 2022 updated by: Organon and Co

A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1225

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: olanzapine
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
Experimental: Arm 1
Drug: 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.
Other Names:
  • Org 5222
  • SCH 900274

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Time Frame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Test
Time Frame: At endpoint
At endpoint
Changes in PANSS subscale scores and Marder factor scores
Time Frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Changes in CGI-S
Time Frame: At each assessment time point from baseline
At each assessment time point from baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Time Frame: At weeks 8, 20, 28, 36, 44 and endpoint
At weeks 8, 20, 28, 36, 44 and endpoint
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Time Frame: At weeks 6, 28 and endpoint
At weeks 6, 28 and endpoint
Resource utilization (as measured by frequency and length of hospital stay)
Time Frame: During the study period
During the study period
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Time Frame: At endpoint
At endpoint
Population kinetics
Time Frame: Plasma samples at weeks 2 and 6 in comparison with baseline
Plasma samples at weeks 2 and 6 in comparison with baseline
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Time Frame: During the study period
During the study period
Safety and tolerability: EPS (AIMS, BARS, SARS)
Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Adverse Events
Time Frame: continuously and up to 7 days after endpoint
continuously and up to 7 days after endpoint
Blood Test
Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Weight and vital signs
Time Frame: at all assessment time points from baseline
at all assessment time points from baseline
ECGs
Time Frame: Weeks 3, 6, 24, and endpoint
Weeks 3, 6, 24, and endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2003

Primary Completion (Actual)

March 15, 2006

Study Completion (Actual)

March 15, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05935
  • ACTAMESA, 25517

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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