NCT00174265

Brief Summary

This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jul 2005

Longer than P75 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 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 5, 2010

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

3.8 years

First QC Date

September 9, 2005

Results QC Date

May 27, 2010

Last Update Submit

February 7, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score

    The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.

    Baseline of A7501013 to Day 365

Secondary Outcomes (1)

  • Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score

    Baseline of A7501013 to Day 365

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:

  • Continue to meet all demographic and procedural
  • this extension trial.
  • Have demonstrated an acceptable degree of compliance
  • and completed the A7501013 trial, and would benefit
  • from continued treatment according to the investigator.

You may not qualify if:

  • Have an uncontrolled, unstable clinically significant
  • medical condition.
  • Have been judged to be medically noncompliant in the
  • management of their disease.

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON 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 9, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

February 9, 2022

Results First Posted

July 5, 2010

Record last verified: 2022-02