Clinical trial NCT00698295: Linear and Non-linear Analysis of EEG Changes in Schizophrenia After Atypical Antipsychotics Medication
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: schizophrenia
atypical antipsychotics
EEG
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Yong-in Mental Hospital
First posted: 2008-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with schizophrenia receiving antipsychotic treatment

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin City
country: Korea, Republic of
facility: Yong-in Mental Hospital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Hospital
name: Yong Sik Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Harris A, Melkonian D, Williams L, Gordon E. Dynamic spectral analysis findings in first episode and chronic schizophrenia. Int J Neurosci. 2006 Mar;116(3):223-46. doi: 10.1080/00207450500402977.
citation: Breakspear M. The nonlinear theory of schizophrenia. Aust N Z J Psychiatry. 2006 Jan;40(1):20-35. doi: 10.1080/j.1440-1614.2006.01737.x.
citation: Wichniak A, Szafranski T, Wierzbicka A, Waliniowska E, Jernajczyk W. Electroencephalogram slowing, sleepiness and treatment response in patients with schizophrenia during olanzapine treatment. J Psychopharmacol. 2006 Jan;20(1):80-5. doi: 10.1177/0269881105056657. Epub 2005 Oct 4.
citation: Chung SJ, Jeong SH, Ahn YM, Kang UG, Koo YJ, Ha JH, Lee SG, Kim YS. A retrospective study of clozapine and electroencephalographic abnormalities in schizophrenic patients. Prog Neuropsychopharmacol Biol Psychiatry. 2002 Jan;26(1):139-44. doi: 10.1016/s0278-5846(01)00238-x.
citation: Kang UG, Par KT, Ahn YM, Koo YJ, Yoon SC, Yi SH, Kim YS. Non-linear dynamic analysis of clozapine-induced electroencephalographic changes in schizophrenic patients--a preliminary study. Prog Neuropsychopharmacol Biol Psychiatry. 2001 Aug;25(6):1229-39. doi: 10.1016/s0278-5846(01)00183-x.