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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698295
Recruitment Status : Unknown
Verified September 2009 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2008
Last Update Posted : September 16, 2009
Yong-in Mental Hospital
Information provided by:
Seoul National University Hospital

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

Condition or disease

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : September 2004
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Biospecimen Retention:   Samples Without DNA
routine lab for changes in medical condition

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with schizophrenia receiving antipsychotic treatment

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698295

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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
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Principal Investigator: Yong Sik Kim, MD, PhD Seoul National University Hospital
Additional Information:
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Responsible Party: Yong Min Ahn/Associate Professor, Seoul National University Hospital Identifier: NCT00698295    
Other Study ID Numbers: 09-2003-009-0
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009
Keywords provided by Seoul National University Hospital:
atypical antipsychotics
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders