NCT01998516

Brief Summary

Scientific Background Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest which focuses on personality traits and abilities enabling people to cope with both their own feelings as well as those of others. The "Mayer-Salovey-Caruso-Emotional-Intelligence-Test" (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the emotional components of social cognition. Recent findings indicate, that social cognitive impairments are useful vulnerability indicators and that EI could be an endophenotype for schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies on EI in BD patients as well as in first degree relatives of patients with schizophrenia or BD haven't been conducted yet. Accordingly, the current study focuses on the four categories assessed by the MSCEIT and aims to compare the task performance of patients, their first degree relatives and healthy control subjects. We assume that the task performance of relatives lies between that of patients and controls. The confirmation of this assumption would verify the trait marker hypothesis and could be a next step to identify a heritable endophenotype for schizophrenia and BD. Hypotheses Compared to healthy control subjects patients suffering from schizophrenia or BD I show deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their task performance lies between that of patients and healthy controls. Deficits in EI are more pronounced in schizophrenia patients than in patients with BD I and are more pronounced in siblings of schizophrenia patients than in siblings of patients with BD I. Independently of diagnosis, deficits in EI affect patients' functional and subjective outcomes. Methods Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia, siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy volunteers matched for age, sex, and educational level. Structured clinical interviews according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II psychiatric disorders (patients, siblings, control subjects). Functional outcome will be assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and Social Performance Scale), subjective quality of life will be examined using the BELP (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to assess premorbid intelligence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration 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

November 12, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

November 12, 2013

Last Update Submit

September 19, 2017

Conditions

Keywords

Emotional Intelligence

Outcome Measures

Primary Outcomes (1)

  • Emotional Intelligence

    Assessed with the MSCEIT (Mayer-Salovey-Caruso-Emotional-Intelligence-Test

    24 month

Secondary Outcomes (1)

  • Quality of Life

    24 month

Study Arms (5)

Schizophrenia Patients

Bipolar I Patients

Siblings of Schizophrenia Patients

Siblings of Bipolar I Patients

Healthy Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psychiatric out- and inpatient setting

You may qualify if:

  • ICD-10 diagnosis of schizophrenia or BD (verified by Mini International Neuropsychiatric Interview (M.I.N.I.)
  • Outpatients with stable psychopathology for at least half a year and fixed treatment regimen for at least one month prior to testing
  • Age: 18-65 years
  • Native German Speakers
  • Written informed consent

You may not qualify if:

  • Other axis 1 disorder (verified by M.I.N.I.)
  • History of organic mental disorder
  • Mental Retardation
  • Epilepsy
  • Pregnancy/breast-feeding
  • Unstable and/or severe organ system diseases, e.g. cardiovascular, endocrine, metabolic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Alex Hofer, Assoc. Prof. Dr.

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 29, 2013

Study Start

December 1, 2013

Primary Completion

December 31, 2016

Study Completion

July 31, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations