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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01998516
Other study ID # KLI 366
Secondary ID
Status Completed
Phase N/A
First received November 12, 2013
Last updated September 19, 2017
Start date December 2013
Est. completion date July 31, 2017

Study information

Verified date September 2017
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date July 31, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck

Sponsors (3)

Lead Sponsor Collaborator
Medical University Innsbruck Austrian Science Fund (FWF), Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotional Intelligence Assessed with the MSCEIT (Mayer-Salovey-Caruso-Emotional-Intelligence-Test 24 month
Secondary Quality of Life Assessed with the Lancashire Quality of Life Profile 24 month
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