Status:
UNKNOWN
Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders
Lead Sponsor:
Seoul National University Hospital
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.
Detailed Description
Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness bas...
Eligibility Criteria
Inclusion
- Male or female patients, 18-65 years of age.
- Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry.
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
Exclusion
- History of taking antipsychotics or mood stabilizers within past 4 weeks.
- History of DSM-IV substance dependence.
- Mental retardation (IQ \< 70)or patients who are not able to understand the informed consent.
- Definite or suspected organic mental disorders.
- Female patients who are not able to maintain contraception during this study
- Laboratory abnormalities with clinical significance
- History of epilepsy or electroconvulsive therapy within the past 3 months.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00330226
Start Date
January 1 2006
End Date
December 1 2012
Last Update
July 23 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744