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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00698295
• Other study ID #: 09-2003-009-0
• Status: Active, not recruiting
• Phase: N/A
• First received: June 15, 2008
• Last updated: September 15, 2009
• Start date: September 2004
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Yong-in Mental Hospital	Yongin City	Gyeonggi-Do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Yong-in Mental Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Breakspear M. The nonlinear theory of schizophrenia. Aust N Z J Psychiatry. 2006 Jan;40(1):20-35. Review. — View 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. — View 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. — View Citation

Higashima M, Takeda T, Kikuchi M, Nagasawa T, Koshino Y. Functional connectivity between hemispheres and schizophrenic symptoms: a longitudinal study of interhemispheric EEG coherence in patients with acute exacerbations of schizophrenia. Clin EEG Neurosci. 2006 Jan;37(1):10-5. — View 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. — View 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. Epub 2005 Oct 4. — View Citation

External Links

•   Click here for brief explanation of the relationship between schizophrenia and EEG.
•   Click here for concise explanation of the meaning of EEG test in schizophrenia.