NCT00212771

Brief Summary

The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment. Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

September 13, 2005

Last Update Submit

February 7, 2022

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in total PANSS score at endpoint

    Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint

Secondary Outcomes (11)

  • Changes in PANSS subscale scores and Marder factor scores

    Every 24 weeks after baseline

  • Changes in CGI-S

    Every 12 weeks after baseline

  • Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)

    Every 48 weeks after baseline

  • Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)

    Every 24 weeks after baseline

  • Resource utilization (as measured by frequency and length of hospital stay)

    During the entire study period

  • +6 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: asenapine

Arm 2

ACTIVE COMPARATOR
Drug: olanzapine

Interventions

asenapineDRUG

Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.

Also known as: Org 5222, SCH 900274
Arm 1
olanzapineDRUG

Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.

Also known as: Zyprexa
Arm 2

Eligibility Criteria

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

You may qualify if:

  • Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

You may not qualify if:

  • Have an uncontrolled, unstable, clinically significant medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schoemaker J, Stet L, Vrijland P, Naber D, Panagides J, Emsley R. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. Pharmacopsychiatry. 2012 Jul;45(5):196-203. doi: 10.1055/s-0031-1301310. Epub 2012 Mar 27.

    PMID: 22454251RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

asenapineOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

October 1, 2006

Last Updated

February 16, 2022

Record last verified: 2022-02