Electrophysiological RandomnessNCT02187835
Decreased EEG Complexity in Schizophrenia
An observational study of Electrophysiological Randomness and Entropy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrophysiological Randomness, Entropy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jan 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: diagnosed with schizophrenia,
Who may be able to join
- diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University, NPIstanbul hospital
Istanbul, Umraniye, 34768
About this study
Official title: Decreased EEG Complexity in Chronic Residual Schizophrenia
Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.
Read the detailed description
Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system
- Conditions
- Electrophysiological Randomness, Entropy
- Keywords
- complexity, electroencephalogram, entropy, negative symptoms, schizophrenia.
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | patients with a diagnosis of schizohrenia | |
| control | healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean of the average Logarithmic Energy Entropy values
Measured: one day
Secondary outcomes (1)
Hurst Exponent value
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrophysiological RandomnessStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokben Hizli Sayar, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187835
- Sponsor's protocol ID
- GHS001
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased EEG Complexity in Chronic Residual Schizophrenia
- ClinicalTrials.gov ID
- NCT02187835
- Acronym / sponsor ID
- GHS001
- Conditions
- Electrophysiological Randomness, Entropy
- Keywords
- complexity, electroencephalogram, entropy, negative symptoms, schizophrenia.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jul 2014 (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.
Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.
Detailed description
Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | –patients with a diagnosis of schizohrenia |
| control | – | –healthy control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosed with schizophrenia,
Key inclusion criteria (1 listed)
- diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S)
Key exclusion criteria (1 listed)
- -
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
the mean of the average Logarithmic Energy Entropy values
Time frame: one day
1 secondary outcome
Hurst Exponent value
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Neuropsychiatry Istanbul Hospital, Istanbul, TurkeyLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Electrophysiological Randomness and Entropy, run by Uskudar University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jul 2014. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
the mean of the average Logarithmic Energy Entropy values (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2014.