NCT00212836

Brief Summary

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
481

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Apr 2005

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

April 21, 2005

Completed
5 months 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

August 13, 2024

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale

    Change from baseline at 6-months

Secondary Outcomes (4)

  • Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale

    Change from baseline at 6-months

  • Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS)

    Change from baseline at 6-months

  • Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)

    Change from baseline at 6-months

  • Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I)

    Change from baseline at 6-months

Study Arms (2)

Asenapine

EXPERIMENTAL
Drug: asenapine

Olanzapine

ACTIVE COMPARATOR
Drug: olanzapine

Interventions

asenapineDRUG

5-10 mg sublingually twice daily for 26 weeks

Asenapine
olanzapineDRUG

5-20 mg by mouth once daily for 26 weeks

Also known as: Zyprexa
Olanzapine

Eligibility Criteria

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

You may qualify if:

  • Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
  • No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
  • Caregiver required.

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)

  • Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.

    PMID: 22198451RESULT

MeSH Terms

Conditions

Schizophrenia

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

April 21, 2005

Primary Completion

June 15, 2007

Study Completion

August 2, 2007

Last Updated

August 15, 2024

Record last verified: 2022-02