Multi-site Communication Deficits in Schizophrenia
1 other identifier
observational
90
1 country
1
Brief Summary
Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 10, 2021
February 1, 2021
6 years
March 15, 2011
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain function
baseline and one-year follow-up
Study Arms (3)
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.
Eligibility Criteria
Three groups of subjects will be included: patients with a first episode of schizophrenia, subjects at increased risk for schizophrenia, and healthy control subjects.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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).
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy, University Hospital Hamburg-Eppendorf (UKE)
Hamburg, 20246, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Mulert, Prof. Dr.
University Medical Center Hamburg-Eppendorf, Department of Psychiatry
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 17, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
February 10, 2021
Record last verified: 2021-02