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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00156104
Collaborator
(none)
460
4
14.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Aug 18, 2006
Actual Study Completion Date :
Sep 16, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Asenapine 5 mg BID

Drug: Asenapine
5 mg BID

Experimental: 2

Asenapine 10 mg BID

Drug: Asenapine
10 mg BID

Active Comparator: 3

Haloperidol 4m mg BID

Drug: Haloperidol
4 mg BID

Placebo Comparator: 4

placebo

Other: Placebo arm

Outcome Measures

Primary Outcome Measures

  1. Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) [Primary outcome measured weekly for 6 weeks]

Secondary Outcome Measures

  1. Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I [At weekly intervals throughout the 6-week trial.]

  2. Neurocognition and cognitive functioning [Baseline and Endpoint ( Day 42)]

  3. CDSS [Days 21 and 42(Endpoint).]

  4. Suicidal thinking ( ISST modified) [Days 14 and 42 (Endpoint)]

  5. Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [Baseline and Day 42(Endpoint)]

  6. Readiness to discharge [At weekly intervals during the 6-week trial]

  7. EPS ( AIMS; BARS; SARS) [At weekly intervals during the 6-week triaL]

  8. Labs; Vital Signs; Weight and girth; ECG [Days 14; 28 and 42 (Endpoint)]

  9. Safety and Tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00156104
Other Study ID Numbers:
  • P05926
  • Hera
  • 41023
First Posted:
Sep 12, 2005
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022