Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00330226

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Bipolar Disorder

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 based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

Study Start Date :

Jan 1, 2006

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Psychopharmacotherapy patients under antipsychotic or mood stabilizer treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.