Linear and Non-linear Analysis of EEG Changes in Schizophrenia After Atypical Antipsychotics Medication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Seoul National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Yong-in Mental Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00698295
First received: June 15, 2008
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to evaluate clinical meaning of EEG changes in antipsychotic-treated patients with schizophrenia.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of the Relationship Between EEG and Clinical Changes in Drug-Naive or Drug-Free Patients With Schizophrenia After Atypical Antipsychotic Treatment Based on Linear and Non-Linear EEG Analysis

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Biospecimen Retention:   Samples Without DNA

routine lab for changes in medical condition


Estimated Enrollment: 60
Study Start Date: September 2004
Estimated Study Completion Date: September 2010
Detailed Description:

Electroencephalographic (EEG) changes are abundant in patients receiving antipsychotic treatment. However, studies on the meaning of these changes are rare. The results of traditional analyses based on linear methodologies were inconsistent and hard to interpret. Therefore, non-linear analyses of EEG may provide additional information in evaluating antipsychotic-induced changes in EEG.

In this study, we hypothesized that linear and non-linear EEG changes in patients with schizophrenia may be valuable in predicting treatment outcome. We also hypothesized that the assessment of other psychotic symptoms and side effects of antipsychotics may provide additional information in interpreting the results of EEG analyses.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with schizophrenia receiving antipsychotic treatment

Criteria

Inclusion Criteria:

  • Male or female patients, 15-65 years of age.
  • Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
  • Patients who are drug-naive or drug-free for more than 4 weeks.
  • Patients who are scheduled to receive atypical antipsychotics.
  • 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.
  • Subjects who are fluent in Korean.

Exclusion Criteria:

  • DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
  • Mental retardation (IQ < 70).
  • Neurological disorders including epilepsy, stroke, or severe head trauma.
  • Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
  • Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline.
  • History of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months.
  • Subjects who are not fluent in Korean.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00698295

Locations
Korea, Republic of
Yong-in Mental Hospital
Yongin City, Gyeonggi-Do, Korea, Republic of, 446-769
Sponsors and Collaborators
Seoul National University Hospital
Yong-in Mental 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: NCT00698295     History of Changes
Other Study ID Numbers: 09-2003-009-0
Study First Received: June 15, 2008
Last Updated: September 15, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
schizophrenia
atypical antipsychotics
EEG

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 September 30, 2014