A randomised, placebo controlled, double blind trial of asenapine in the prevention of relapse after long term treatment of schizophrenia.
- Conditions
- Schizophrenia
- Registration Number
- EUCTR2004-003340-22-LV
- Lead Sponsor
- Pfizer Luxembourg SARL Latvia Branch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 447
1. at least 18 years of age,
2. signed informed consent,
3. a male, or a woman who is not of child-bearing potential (and breastfeeding),
4. fluent in the language of an investigator and study staff,
5. having a caregiver or an identified responsible person,
6. having access to appropriate supervision during the randomized treatment period,
7. primary diagnosis of schizophreania
8. documented history of at least 1 year episode of acute schizophrenia
9. antipsychotic treatment required for at least 2 years
etc.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method