This trial is active, not recruiting.

Condition schizophrenia
Sponsor Seoul National University Hospital
Collaborator Yong-in Mental Hospital
Start date September 2004
End date September 2010
Trial size 60 participants
Trial identifier NCT00698295, 09-2003-009-0


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Eligibility Criteria

Male or female participants from 15 years up to 65 years old.

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.

Additional Information

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
Principal investigator Yong Sik Kim, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.