NCT00330226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

First QC Date

May 25, 2006

Last Update Submit

July 21, 2010

Conditions

SchizophreniaBipolar Disorder

Keywords

schizophreniabipolar disorderatypical antipsychoticsmood stabilizersbiological markers

Study Arms (1)

Psychopharmacotherapy

patients under antipsychotic or mood stabilizer treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with schizophrenia or bipolar disorder receiving pharmacotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related 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. doi: 10.1016/s0165-0327(01)00377-9.

    PMID: 12063145BACKGROUND

  • 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.

    PMID: 16026484BACKGROUND

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

    PMID: 2885912BACKGROUND

  • 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.

    PMID: 15025545BACKGROUND

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

    PMID: 8782289BACKGROUND

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

    PMID: 15693746BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

regular lab tests for evaluating the changes in medical condition

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Yong Sik Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Seung Chang, MD

CONTACT

82 31 787 7437cjs0107@snu.ac.kr

Se Hyun Kim, MD

CONTACT

82 2 2072 3767sh3491@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2006

First Posted

May 26, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2012

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations

KR(1)