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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00330226
First received: May 25, 2006
Last updated: July 21, 2010
Last verified: July 2010

May 25, 2006
July 21, 2010
January 2006
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Complete list of historical versions of study NCT00330226 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders
Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

regular lab tests for evaluating the changes in medical condition

Probability Sample

patients with schizophrenia or bipolar disorder receiving pharmacotherapy

  • Schizophrenia
  • Bipolar Disorder
Not Provided
Psychopharmacotherapy
patients under antipsychotic or mood stabilizer treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2012
Not Provided

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.
Both
18 Years to 65 Years
No
Contact: Jae Seung Chang, MD 82 31 787 7437 cjs0107@snu.ac.kr
Contact: Se Hyun Kim, MD 82 2 2072 3767 sh3491@snu.ac.kr
Korea, Republic of
 
NCT00330226
KYS-2006-05318
Yes
Yong Min Ahn/Associate Professor, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Yong Sik Kim, MD, PhD Seoul National University Hospital
Seoul National University Hospital
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP