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

NCT ID: NCT00156104

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-01
• Study Completion Date: 2006-09-16

Brief Summary

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Asenapine 5 mg BID

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

5 mg BID

2

Asenapine 10 mg BID

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

10 mg BID

3

Haloperidol 4m mg BID

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

4 mg BID

4

placebo

Group Type: PLACEBO_COMPARATOR

Placebo arm

Intervention Type: OTHER

Interventions

Asenapine

5 mg BID

Intervention Type: DRUG

Asenapine

10 mg BID

Intervention Type: DRUG

Haloperidol

4 mg BID

Intervention Type: DRUG

Placebo arm

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Kane JM, Cohen M, Zhao J, Alphs L, Panagides J. Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol. 2010 Apr;30(2):106-15. doi: 10.1097/JCP.0b013e3181d35d6b.

Reference Type: RESULT

PMID: 20520283 (View on PubMed)

Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20. doi: 10.3371/CSRP.CAJE.103114.

Reference Type: DERIVED

PMID: 25367164 (View on PubMed)

Other Identifiers

Hera

Identifier Type: -

Identifier Source: secondary_id

41023

Identifier Type: -

Identifier Source: secondary_id

P05926

Identifier Type: -

Identifier Source: org_study_id