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OpenTrials
Completed

NCT Number: NCT00212771

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

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

Olanzapine

Drug

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

Other names: Zyprexa

Primary outcomes

  1. Change in total PANSS score at endpoint

    Time frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint

Secondary outcomes

  1. Changes in PANSS subscale scores and Marder factor scores

    Time frame: Every 24 weeks after baseline

  2. Changes in CGI-S

    Time frame: Every 12 weeks after baseline

  3. Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)

    Time frame: Every 48 weeks after baseline

  4. Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)

    Time frame: Every 24 weeks after baseline

  5. Resource utilization (as measured by frequency and length of hospital stay)

    Time frame: During the entire study period

  6. Safety and tolerability: EPS (AIMS, BARS, SARS)

    Time frame: Every 24 weeks after baseline

  7. Adverse Events

    Time frame: Continuously and up to 7 days after endpoint

  8. Pregnancy Test

    Time frame: At endpoint

  9. Blood Tests

    Time frame: Every 12 weeks after baseline

  10. Weight and vital signs

    Time frame: Every 4 weeks after baseline

  11. ECGs

    Time frame: Every 24 weeks after baseline

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Acronym: ACTAMESA

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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