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NCT00330226 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00330226
Other study ID # KYS-2006-05318
Secondary ID
Status Recruiting
Phase N/A
First received May 25, 2006
Last updated July 21, 2010
Start date January 2006
Est. completion date December 2012

Study information
Verified date July 2010
Source Seoul National University Hospital
Contact Jae Seung Chang, MD
Phone 82 31 787 7437
Email cjs0107@snu.ac.kr
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

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

Kane JM. Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56. — View Citation

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

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

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

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