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OpenTrials
Completed

NCT Number: NCT00156104

Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

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 inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.

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Key information

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. Caregiver required.

Exclusion criteria

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

Treatment and study plan

asenapine

Drug

5 mg BID

Haloperidol

Drug

4 mg BID

Placebo arm

Other

Primary outcomes

  1. Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)

    Time frame: Primary outcome measured weekly for 6 weeks

Secondary outcomes

  1. Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I

    Time frame: At weekly intervals throughout the 6-week trial.

  2. Neurocognition and cognitive functioning

    Time frame: Baseline and Endpoint ( Day 42)

  3. CDSS

    Time frame: Days 21 and 42(Endpoint).

  4. Suicidal thinking ( ISST modified)

    Time frame: Days 14 and 42 (Endpoint)

  5. Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test

    Time frame: Baseline and Day 42(Endpoint)

  6. Readiness to discharge

    Time frame: At weekly intervals during the 6-week trial

  7. EPS ( AIMS; BARS; SARS)

    Time frame: At weekly intervals during the 6-week triaL

  8. Labs; Vital Signs; Weight and girth; ECG

    Time frame: Days 14; 28 and 42 (Endpoint)

  9. Safety and Tolerability

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 12, 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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