Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

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Organon

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: asenapine
Drug: olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00156117
Hera
41021
P05933

Details and patient eligibility

About

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.

Enrollment

417 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

417 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
asenapine 5 mg BID and 10 mg BID
Treatment:
Drug: asenapine
2
Placebo Comparator group
Description:
Placebo against olanzapine and asenapine
Treatment:
Drug: Placebo
3
Active Comparator group
Description:
olanzapine 15 mgQD
Treatment:
Drug: olanzapine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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