NCT01317121

Brief Summary

Multi-site Communication Deficits Underlying Cognitive Dysfunction in the Prodromal Phase and First Episode of Schizophrenia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

March 15, 2011

Last Update Submit

February 9, 2021

Conditions

Keywords

Patients with a first episode of schizophreniaSubjects at risk for psychosis

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

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

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Christoph Mulert, Prof. Dr.

    University Medical Center Hamburg-Eppendorf, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

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

Locations