NCT00212784

Brief Summary

The primary features of schizophrenia and schizoaffective disorder are characterized by 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 or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,225

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Sep 2003

Typical duration 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

September 4, 2003

Completed
2 years 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

September 13, 2005

Last Update Submit

August 13, 2024

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline

    Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)

Secondary Outcomes (14)

  • Changes in PANSS subscale scores and Marder factor scores

    At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint

  • Changes in CGI-S

    At each assessment time point from baseline

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

    At weeks 8, 20, 28, 36, 44 and endpoint

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

    At weeks 6, 28 and endpoint

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

    During the study period

  • +9 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

Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

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. Subject must sign a written informed consent.

You may not qualify if:

  • Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.

    PMID: 20205074RESULT

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 4, 2003

Primary Completion

March 15, 2006

Study Completion

March 15, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02