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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00212784
Other study ID # P05935
Secondary ID ACTAMESA, 25517
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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