SchizophreniaNCT01317121
Multi-site Communication Deficits in Schizophrenia
An observational study of Schizophrenia and Psychosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode 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
- Schizophrenia, Psychosis
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jul 2017
- 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: Three groups of subjects will be included: patients with a first episode of schizophrenia, subjects at increased risk for schizophrenia, and healthy control subjects.
Who may be able to join
- Signed written informed consent.
- Inpatients of the Clinic for Psychiatry and Psychotherapy of the University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
- Diagnosis of schizophrenia according to ICD-10 and DSM-IV criteria.
- Signed written informed consent.
- Outpatients of the early diagnosis center of the University Department of Psychiatry at the University Hospital Hamburg-Eppendorf (UKE)Germany.
- Meeting high risk criteria for schizophrenia according to the Structured Interview for Prodromal Syndromes (SIPS).
- Signed written informed consent.
- Healthy male and female subjects recruited from students and hospital staff of the University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
Who cannot join
- Epilepsy or other disorders of the nervous system, further psychiatric or neurological disorders.
- Suicidal tendencies.
- Acute or lifetime alcohol abuse.
- Hearing impairment.
- Intelligence quotient (IQ) below average.
- Non-magnetoencephalography(MEG)/ magnetic resonance imaging(MRI) compatible metallic implants.
Show all 21Show fewer
- Epilepsy or other disorders of the nervous system, further psychiatric or neurological disorders.
- Suicidal tendencies.
- Acute or lifetime alcohol abuse.
- Hearing impairment.
- IQ below average.
- Non-MEG/MRI compatible metallic implants.
- Acute or lifetime psychiatric disorder.
- Suicidal tendencies.
- Epilepsy or other disorders of the nervous system.
- First degree relative with a psychiatric disorder.
- Intake of medication affecting the central nervous system.
- Acute or lifetime alcohol abuse.
- Hearing impairment.
- IQ below average.
- Non-MEG/MRI compatible metallic implants.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University Hospital Hamburg-Eppendorf (UKE)
Hamburg, 20246
About this study
Official title: Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
Read the detailed description
Abnormal long-range connectivity between brain areas and corresponding impaired synchronization of oscillatory rhythms in neuronal networks represent an important pathophysiological mechanism underlying schizophrenia. Although schizophrenia is considered as a neurodevelopmental disorder the mechanisms by which the abnormal neural circuitry and communication develops before the onset of clinical symptoms are unknown. This project aims to investigate the relationship between disturbed neural synchronization and cognitive deficits in the prodromal phase of schizophrenia and is intended to identify patients with increased risk for developing schizophrenia. Present approaches to describe subjects at risk for psychosis based on clinical features have not been completely convincing since psychiatric symptoms in the prodromal phase are often too unspecific. Recent studies suggest that detecting cognitive deficits might help for a more precise identification of high risk subjects. However, the underlying neurophysiological mechanisms have not yet been investigated sufficiently. Precise identification of subjects with high risk for switching to schizophrenia would be very important since interventional strategies such as medical treatment even with second generation antipsychotics are not completely free of risk and therefore should be limited to subjects with a maximal benefit. In this project subjects at risk for psychosis will be investigated with electroencephalography (EEG), magnetoencephalography (MEG) and simultaneous electroencephalography-functional magnetic resonance imaging (EEG-fMRI). Follow up investigations will be performed after switching to schizophrenia has occurred or not. Neural synchronization between the prefrontal cortex and the hippocampal formation will be investigated using a working memory paradigm. Here, different levels of memory load will be investigated using the n-back paradigm. Earlier studies showed disturbed functional and effective connectivity between the hippocampus and the prefrontal cortex both in patients with schizophrenia and subjects at risk. Neural synchronization between the prefrontal cortex and sensory areas will be investigated with different attentional paradigms. Here, tones will be presented that have to be responded to by button press. Earlier studies demonstrated disturbed auditory evoked gamma oscillations in patients with schizophrenia and unaffected siblings. Neural oscillations will be recorded with 64-channel EEG and localized by means of simultaneous functional magnetic resonance imaging (fMRI). Integration of EEG and fMRI will be performed using single-trial coupling in order to detect brain regions involved in specific oscillatory rhythms. Using both paradigms, neural long-range synchronization will be analyzed. In addition, dynamic causal modelling will be used for further characterization of functional relationships among brain regions involved. The investigators expect a functional relationship between cognitive deficits in subjects with prodromal schizophrenia and subjects with a first episode of schizophrenia with regards to long range neural synchronization. In addition, the investigators expect to identify subjects at high risk for schizophrenia with the analysis of disturbed long range synchronization.
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Patients with a first episode of schizophrenia, Subjects at risk for psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
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 |
|---|---|---|
| Subjects at risk for psychosis | Identification and clinical characterization of subjects with prodromal symptoms will be done in the early diagnosis outpatient center of the University Department of Psychiatry in Hamburg, Germany. Subjects At Risk Mental State (ARMS) for psychosis will be identified if they meet the criteria of the Structured Interview for Prodromal Syndromes (SIPS) (McGlashan et al 2001). | |
| Patients with a first episode of schizophrenia | Patients with a first episode of schizophrenia will be recruited from inpatients at the Clinic for Psychiatry and Psychotherapy at the University Hospital (UKE) in Hamburg, Germany. All patients have to meet criteria for DSM-IV and ICD-10 diagnosis for schizophrenia. | |
| Healthy control subjects | Healthy control subjects will be recruited from the hospital staff and students at the University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany. They have to be free from any neurological or psychiatric disorder, according to DSM-IV and ICD-10 criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain function
Measured: baseline and one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CMulert, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Christoph Mulert, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317121
- Sponsor's protocol ID
- NeuroSFB-PV3632
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2011
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
- ClinicalTrials.gov ID
- NCT01317121
- Acronym / sponsor ID
- NeuroSFB-PV3632
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Patients with a first episode of schizophrenia, Subjects at risk for psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Mar 2011 (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.
Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
Detailed description
Abnormal long-range connectivity between brain areas and corresponding impaired synchronization of oscillatory rhythms in neuronal networks represent an important pathophysiological mechanism underlying schizophrenia. Although schizophrenia is considered as a neurodevelopmental disorder the mechanisms by which the abnormal neural circuitry and communication develops before the onset of clinical symptoms are unknown. This project aims to investigate the relationship between disturbed neural synchronization and cognitive deficits in the prodromal phase of schizophrenia and is intended to identify patients with increased risk for developing schizophrenia. Present approaches to describe subjects at risk for psychosis based on clinical features have not been completely convincing since psychiatric symptoms in the prodromal phase are often too unspecific. Recent studies suggest that detecting cognitive deficits might help for a more precise identification of high risk subjects. However, the underlying neurophysiological mechanisms have not yet been investigated sufficiently. Precise identification of subjects with high risk for switching to schizophrenia would be very important since interventional strategies such as medical treatment even with second generation antipsychotics are not completely free of risk and therefore should be limited to subjects with a maximal benefit. In this project subjects at risk for psychosis will be investigated with electroencephalography (EEG), magnetoencephalography (MEG) and simultaneous electroencephalography-functional magnetic resonance imaging (EEG-fMRI). Follow up investigations will be performed after switching to schizophrenia has occurred or not. Neural synchronization between the prefrontal cortex and the hippocampal formation will be investigated using a working memory paradigm. Here, different levels of memory load will be investigated using the n-back paradigm. Earlier studies showed disturbed functional and effective connectivity between the hippocampus and the prefrontal cortex both in patients with schizophrenia and subjects at risk. Neural synchronization between the prefrontal cortex and sensory areas will be investigated with different attentional paradigms. Here, tones will be presented that have to be responded to by button press. Earlier studies demonstrated disturbed auditory evoked gamma oscillations in patients with schizophrenia and unaffected siblings. Neural oscillations will be recorded with 64-channel EEG and localized by means of simultaneous functional magnetic resonance imaging (fMRI). Integration of EEG and fMRI will be performed using single-trial coupling in order to detect brain regions involved in specific oscillatory rhythms. Using both paradigms, neural long-range synchronization will be analyzed. In addition, dynamic causal modelling will be used for further characterization of functional relationships among brain regions involved. The investigators expect a functional relationship between cognitive deficits in subjects with prodromal schizophrenia and subjects with a first episode of schizophrenia with regards to long range neural synchronization. In addition, the investigators expect to identify subjects at high risk for schizophrenia with the analysis of disturbed long range synchronization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects at risk for psychosis | – | –Identification and clinical characterization of subjects with prodromal symptoms will be done in the early diagnosis outpatient center of the University Department of Psychiatry in Hamburg, Germany. Subjects At Risk Mental State (ARMS) for psychosis will be identified if they meet the criteria of the Structured Interview for Prodromal Syndromes (SIPS) (McGlashan et al 2001). |
| Patients with a first episode of schizophrenia | – | –Patients with a first episode of schizophrenia will be recruited from inpatients at the Clinic for Psychiatry and Psychotherapy at the University Hospital (UKE) in Hamburg, Germany. All patients have to meet criteria for DSM-IV and ICD-10 diagnosis for schizophrenia. |
| Healthy control subjects | – | –Healthy control subjects will be recruited from the hospital staff and students at the University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany. They have to be free from any neurological or psychiatric disorder, according to DSM-IV and ICD-10 criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of subjects will be included: patients with a first episode of schizophrenia, subjects at increased risk for schizophrenia, and healthy control subjects.
Key inclusion criteria (8 listed)
- Signed written informed consent.
- Inpatients of the Clinic for Psychiatry and Psychotherapy of the University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany.
- Diagnosis of schizophrenia according to ICD-10 and DSM-IV criteria.
- Signed written informed consent.
- Outpatients of the early diagnosis center of the University Department of Psychiatry at the University Hospital Hamburg-Eppendorf (UKE)Germany.
Key exclusion criteria (21 listed)
- Epilepsy or other disorders of the nervous system, further psychiatric or neurological disorders.
- Suicidal tendencies.
- Acute or lifetime alcohol abuse.
- Hearing impairment.
- Intelligence quotient (IQ) below average.
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
Brain function
Time frame: baseline and one-year follow-up
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 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
Christoph Mulert, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Department of Psychiatry
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 and Psychosis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 8 inclusion and 21 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 10 Feb 2021. 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 Germany. 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?
Brain function (time frame: baseline and one-year follow-up). 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 10 Feb 2021.