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

NCT ID: NCT00330226

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Psychopharmacotherapy

patients under antipsychotic or mood stabilizer treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Yong Sik Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Seung Chang, MD

Role: CONTACT

82 31 787 7437

Se Hyun Kim, MD

Role: CONTACT

82 2 2072 3767

References

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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.

Reference Type BACKGROUND
PMID: 12063145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16026484 (View on PubMed)

Kane JM. Treatment of schizophrenia. Schizophr Bull. 1987;13(1):133-56. doi: 10.1093/schbul/13.1.133.

Reference Type BACKGROUND
PMID: 2885912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15025545 (View on PubMed)

McGlashan TH. Early detection and intervention in schizophrenia: research. Schizophr Bull. 1996;22(2):327-45. doi: 10.1093/schbul/22.2.327.

Reference Type BACKGROUND
PMID: 8782289 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15693746 (View on PubMed)

Related Links

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http://www.nlm.nih.gov/medlineplus/schizophrenia.html

Click here for the information about schizophrenia.

Other Identifiers

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KYS-2006-05318

Identifier Type: -

Identifier Source: org_study_id

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