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Completed

NCT Number: NCT00212784

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

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.

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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. 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.

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

Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

Primary outcomes

  1. 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)

Secondary outcomes

  1. Changes in PANSS subscale scores and Marder factor scores

    Time frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint

  2. Changes in CGI-S

    Time frame: At each assessment time point from baseline

  3. 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

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

    Time frame: At weeks 6, 28 and endpoint

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

    Time frame: During the study period

  6. Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)

    Time frame: At endpoint

  7. Population kinetics

    Time frame: Plasma samples at weeks 2 and 6 in comparison with baseline

  8. 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

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

    Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint

  10. Adverse Events

    Time frame: continuously and up to 7 days after endpoint

  11. Pregnancy Test

    Time frame: At endpoint

  12. Blood Test

    Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint

  13. Weight and vital signs

    Time frame: at all assessment time points from baseline

  14. ECGs

    Time frame: Weeks 3, 6, 24, and endpoint

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Aug 15, 2024

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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