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

This study is currently recruiting participants.

Verified by Seoul National University Hospital, July 2007

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00330226

Purpose

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
Schizophrenia Bipolar Disorder

MedlinePlus related topics: Bipolar Disorder Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

Further study details as provided by Seoul National University Hospital:

Estimated Enrollment:	500
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2008

Groups/Cohorts
A: Case patients under antipsychotic or mood stabilizer treatment

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330226

Contacts

Contact: Jae Seung Chang, MD	82 2 2072 1987	cjs0107@snu.ac.kr
Contact: Se Hyun Kim, MD	82 2 2072 3767	sh3491@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Yong Sik Kim, MD, PhD

Seoul National University Hospital

More Information

Click here for comprehensive explanation of bipolar disorder. This link exits the ClinicalTrials.gov site

Click here for the information about schizophrenia. This link exits the ClinicalTrials.gov site

Publications:

Angst F, Stassen HH, Clayton PJ, Angst J. Mortality of patients with mood disorders: follow-up over 34-38 years. J Affect Disord. 2002 Apr;68(2-3):167-81.

Dunner DL. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar Disord. 2005 Aug;7(4):307-25. Review.

Kane JM. Treatment of schizophrenia. Schizophr Bull 13:133-156, 1987.

Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics: literature review and clinical implications. Drugs. 2004;64(7):701-23. Review.

McGlashan TH. Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. Review.

Swann AC. Long-term treatment in bipolar disorder. J Clin Psychiatry. 2005;66 Suppl 1:7-12. Review.

Study ID Numbers:	KYS-2006-05318
Study First Received:	May 25, 2006
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00330226
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

schizophrenia
bipolar disorder
atypical antipsychotics
mood stabilizers
biological markers

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009