Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

Schizophrenia Clinical Trial

Official title:

A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212784
• Other study ID #: P05935
• Secondary ID: ACTAMESA, 25517
• Status: Completed
• Phase: Phase 3
• Start date: September 4, 2003
• Est. completion date: March 15, 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: March 15, 2006
• Est. primary completion date: March 15, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• asenapine
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.
• olanzapine
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in PANSS subscale scores and Marder factor scores		At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Secondary	Changes in CGI-S		At each assessment time point from baseline
Secondary	Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)		At weeks 8, 20, 28, 36, 44 and endpoint
Secondary	Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)		At weeks 6, 28 and endpoint
Secondary	Resource utilization (as measured by frequency and length of hospital stay)		During the study period
Secondary	Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)		At endpoint
Secondary	Population kinetics		Plasma samples at weeks 2 and 6 in comparison with baseline
Secondary	Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)		During the study period
Secondary	Safety and tolerability: EPS (AIMS, BARS, SARS)		At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Secondary	Adverse Events		continuously and up to 7 days after endpoint
Secondary	Pregnancy Test		At endpoint
Secondary	Blood Test		At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Secondary	Weight and vital signs		at all assessment time points from baseline
Secondary	ECGs		Weeks 3, 6, 24, and endpoint