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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00330226
First received: May 25, 2006
Last updated: July 21, 2010
Last verified: July 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Biospecimen Retention:   Samples Without DNA

regular lab tests for evaluating the changes in medical condition


Estimated Enrollment: 500
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Groups/Cohorts
Psychopharmacotherapy
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
Sampling Method:   Probability Sample
Study Population

patients with schizophrenia or bipolar disorder receiving pharmacotherapy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Jae Seung Chang, MD 82 31 787 7437 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

Additional Information:
Publications:
Responsible Party: Yong Min Ahn/Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00330226     History of Changes
Other Study ID Numbers: KYS-2006-05318
Study First Received: May 25, 2006
Last Updated: July 21, 2010
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

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 20, 2014