Clinical trial NCT00330226: Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders
Official title: Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Bipolar Disorder
Keywords: schizophrenia
bipolar disorder
atypical antipsychotics
mood stabilizers
biological markers
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-05-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with schizophrenia or bipolar disorder receiving pharmacotherapy

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Sik Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0165-0327(01)00377-9.
citation: Dunner DL. Safety and tolerability of emerging pharmacological treatments for bipolar disorder. Bipolar Disord. 2005 Aug;7(4):307-25. doi: 10.1111/j.1399-5618.2005.00235.x.
citation: Kane JM. Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56. doi: 10.1093/schbul/13.1.133.
citation: Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics: literature review and clinical implications. Drugs. 2004;64(7):701-23. doi: 10.2165/00003495-200464070-00003.
citation: McGlashan TH. Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. doi: 10.1093/schbul/22.2.327.
citation: Swann AC. Long-term treatment in bipolar disorder. J Clin Psychiatry. 2005;66 Suppl 1:7-12.