NCT00698295

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

First QC Date

June 15, 2008

Last Update Submit

September 15, 2009

Conditions

Schizophrenia

Keywords

schizophreniaatypical antipsychoticsEEG

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with schizophrenia receiving antipsychotic treatment

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yong-in Mental Hospital

Yongin City, Gyeonggi-do, 446-769, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 16475479BACKGROUND

  • 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.

    PMID: 16484051BACKGROUND

  • 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.

    PMID: 16403034BACKGROUND

  • 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.

    PMID: 16204327BACKGROUND

  • 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.

    PMID: 11853104BACKGROUND

  • 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.

    PMID: 11474842BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

routine lab for changes in medical condition

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Yong Sik Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2008

First Posted

June 17, 2008

Study Start

September 1, 2004

Study Completion

September 1, 2010

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

KR(1)