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OpenTrials
Completed

NCT Number: NCT00151424

Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. 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 is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

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Key information

Conditions

Schizophrenia Mental Disorders 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

  • Currently suffering from an acute exacerbation of schizophrenia.

Exclusion criteria

  • Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.

Treatment and study plan

asenapine

Drug

Asenapine 5-10mgBID

Placebo

Drug

Matched against asenapine and olanzapine

Olanzapine

Drug

10-20 mg QD

Primary outcomes

  1. Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline

    Time frame: Screen, baseline, days 4, 7, 14, 21, 28, 35, 42

    A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).

Secondary outcomes

  1. Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores

    Time frame: Screen, baseline, Days 4,7,14,21,28,35,42

    This was not a prespecified key secondary outcome

  2. Clinical Global Impression Improvement (CGI-I) scores

    Time frame: Days 4,7,14,21,28,35,42

    This was not a prespecified key secondary outcome

  3. Neurocognition and cognitive functioning

    Time frame: Baseline , day 42

    This was not a prespecified key secondary outcome

  4. Anxiety

    Time frame: Baseline, day 42

    This was not a prespecified key secondary outcome

  5. Suicidal thinking

    Time frame: Baseline, day 42

    This was not a prespecified key secondary outcome

  6. Quality of life and patient functionality

    Time frame: Baseline, day 42

    This was not a prespecified key secondary outcome

  7. Readiness to discharge, at scheduled assessments and endpoint from baseline

    Time frame: Baseline up to day 14

    This was not a prespecified key secondary outcome

  8. Extrapyramidal symptoms

    Time frame: Baseline, Days 4,7,14,21,28,35,42

    This was not a prespecified key secondary outcome

  9. Laboratory parameters

    Time frame: Baseline, Days 14,,28,,42

    This was not a prespecified key secondary outcome

  10. Vital signs

    Time frame: Baseline, Days ,14,21,28,42

    This was not a prespecified key secondary outcome

  11. Weight

    Time frame: Baseline, Days 14,,28,,42

    This was not a prespecified key secondary outcome

  12. Electrocardiograms (ECGs)

    Time frame: Baseline, Days ,14, 28, 42

    This was not a prespecified key secondary outcome

  13. Adverse events (including serious adverse events)

    Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint

    This was not a prespecified key secondary outcome

  14. Serious adverse events (SAEs) up to 30 days after endpoint

    Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint

    This was not a prespecified key secondary outcome

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Flexible-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 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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