To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

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Organon

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Asenapine - Open Label
Drug: Placebo - Double Blind
Drug: Asenapine - Double Blind

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150176
P05770
A7501012

Details and patient eligibility

About

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.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 may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Enrollment

831 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Have a primary diagnosis of schizophrenia
  • History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
  • History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
  • Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant medical condition
  • History of suicide attempt or significant violence to others in the past 2 years
  • A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
  • Current substance abuse/dependence
  • Concurrent psychiatric disorder other than schizophrenia.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

831 participants in 2 patient groups, including a placebo group

asenapine
Experimental group
Treatment:
Drug: Asenapine - Double Blind
Drug: Asenapine - Open Label
placebo
Placebo Comparator group
Treatment:
Drug: Placebo - Double Blind
Drug: Asenapine - Open Label

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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