Linear and Non-linear Analysis of EEG Changes in Schizoph... | NCT00698295

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

NCT00698295

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 16, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Sep 2010Estimated

First Submitted Date

Jun 15, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2009

Last Update Posted Date

Sep 16, 2009Estimated

Name	Class
Yong-in Mental Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients with schizophrenia receiving antipsychotic treatment

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Yong Sik Kim, MD, PhD	Seoul National University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yong-in Mental Hospital		Yongin City	Gyeonggi-do	446-769	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16475479	Background	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. doi: 10.1177/155005940603700104.
16484051	Background

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders