Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212771

Acronym

ACTAMESA

Enrollment

440

Registered

2005-09-21

Start date

2004-09-30

Completion date

2006-10-31

Last updated

2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

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.

Interventions

DRUGasenapine

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.

DRUGolanzapine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in total PANSS score at endpoint	Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint

Secondary

Measure	Time frame
ECGs	Every 24 weeks after baseline
Adverse Events	Continuously and up to 7 days after endpoint
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
Safety and tolerability: EPS (AIMS, BARS, SARS)	Every 24 weeks after baseline
Pregnancy Test	At endpoint
Blood Tests	Every 12 weeks after baseline
Weight and vital signs	Every 4 weeks after baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026