SchizophreniaNCT00698295
Linear and Non-linear Analysis of EEG Changes in Schizophrenia After Atypical Antipsychotics Medication
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate clinical meaning of EEG changes in antipsychotic-treated patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2004to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with schizophrenia receiving antipsychotic treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yong-in Mental Hospital
Yongin City, Gyeonggi-do, 446-769
About this study
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
The purpose of this study is to evaluate clinical meaning of EEG changes in antipsychotic-treated patients with schizophrenia.
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, atypical antipsychotics, EEG
- Medical subject headings
- Schizophrenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startSep 2004
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yong-in Mental Hospital
- Investigators
- Yong Sik Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698295
- Sponsor's protocol ID
- 09-2003-009-0
- Status last verified
- Sep 2009
- First submitted
- 15 Jun 2008
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16475479Harris 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.
PubMed 16484051Breakspear 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.
PubMed 16403034Wichniak 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.
PubMed 16204327Chung 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.
PubMed 11853104Kang 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.
PubMed 11474842
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698295
- Acronym / sponsor ID
- 09-2003-009-0
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, atypical antipsychotics, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Yong-in Mental Hospital
- Study start
- Sep 2004
- Study completion
- Sep 2010 (estimated)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with schizophrenia receiving antipsychotic treatment
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
- Background: PubMed 16475479Higashima 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.
- Background: PubMed 16484051Harris 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.
- Background: PubMed 16403034Breakspear 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.
- Background: PubMed 16204327Wichniak 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.
- Background: PubMed 11853104Chung 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.
- Background: PubMed 11474842Kang 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.
- Click here for brief explanation of the relationship between schizophrenia and EEG.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Sik Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698295, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2009.