NCT00156104

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2006

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

September 7, 2005

Last Update Submit

August 13, 2024

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

    Primary outcome measured weekly for 6 weeks

Secondary Outcomes (9)

  • 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.

  • Neurocognition and cognitive functioning

    Baseline and Endpoint ( Day 42)

  • CDSS

    Days 21 and 42(Endpoint).

  • Suicidal thinking ( ISST modified)

    Days 14 and 42 (Endpoint)

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

    Baseline and Day 42(Endpoint)

  • +4 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Asenapine 5 mg BID

Drug: Asenapine

2

EXPERIMENTAL

Asenapine 10 mg BID

Drug: Asenapine

3

ACTIVE COMPARATOR

Haloperidol 4m mg BID

Drug: Haloperidol

4

PLACEBO COMPARATOR

placebo

Other: Placebo arm

Interventions

AsenapineDRUG

5 mg BID

1
HaloperidolDRUG

4 mg BID

3
Placebo armOTHER
4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20520283RESULT

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

    PMID: 25367164DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

asenapineHaloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

July 1, 2005

Primary Completion

August 18, 2006

Study Completion

September 16, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02