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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330226
Recruitment Status : Unknown
Verified July 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 26, 2006
Last Update Posted : July 23, 2010
Information provided by:
Seoul National University Hospital

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
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 Type : Observational
Estimated 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 : January 2006
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

patients under antipsychotic or mood stabilizer treatment

Biospecimen Retention:   Samples Without DNA
regular lab tests for evaluating the changes in medical condition

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with schizophrenia or bipolar disorder receiving pharmacotherapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330226

Contact: Jae Seung Chang, MD 82 31 787 7437
Contact: Se Hyun Kim, MD 82 2 2072 3767

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Yong Sik Kim, MD, PhD Seoul National University Hospital

Additional Information:
Responsible Party: Yong Min Ahn/Associate Professor, Seoul National University Hospital Identifier: NCT00330226     History of Changes
Other Study ID Numbers: KYS-2006-05318
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by Seoul National University Hospital:
bipolar disorder
atypical antipsychotics
mood stabilizers
biological markers

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs