Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects

NCT02575209 | Completed

• 1 other identifier: 2015534
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with schizophrenia have important and persistent deficits in multiple neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental operations underlying social behavior, and it is understood as a multidimensional construct that comprises emotional processing (EP), social perspective and knowledge, attributional bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired in chronic schizophrenia patients as well as in patients in early stages of the illness. In this context, although negative symptoms may play and important role, females seem to perform better than males in ToM and EP tasks, suggesting the presence of gender differences in the SC skills in patients with schizophrenia. However, to our knowledge, there are no studies that have explored the gender-related differences between cognitive and affective ToM and its relationship with the EP performance in schizophrenia patients of recent diagnosis comparing with healthy subjects. In this line, the main objective of this project is to analyze the influence of gender in the cognitive and affective ToM abilities, in a group of patients with schizophrenia in early stages of the illness comparing with healthy subjects. Secondarily, this study pretends to explore the association between EP skills and affective ToM tasks performance in males and females with and without recent diagnosis of schizophrenia.

Conditions

Women With Recent Diagnosis of Schizophrenia; Men With Recent Diagnosis of Schizophrenia; Healthy Women; Healthy Men

Outcome Measures

Primary Outcomes (2)

• Affective Theory of Mind

  Measured by: Reading the Mind in the Eyes test (RMET)

  Through study completion, an average of 6 months

• Cognitive Theory of Mind

  Measured by: False belief stories

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Emotional Processing

  Through study completion, an average of 6 months

• Psychosis Symptoms

  Through study completion, an average of 6 months

Other Outcomes (2)

• Intelligence Quotient (IQ) in schizophrenia groups

  Through study completion, an average of 6 months

• Intelligence Quotient (IQ) in healthy groups

  Through study completion, an average of 6 months

Study Arms (4)

Women schiz.

Women with recent diagnosis of schizophrenia

Other: GENDER

Men schiz.

Men with recent diagnosis of schizophrenia

Other: GENDER

Women healthy

Women without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis

Other: GENDER

Men healthy

Men without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis

Other: GENDER

Interventions

GENDER OTHER

Men healthy; Men schiz.; Women healthy; Women schiz.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females and males with and without schizophrenia of recent diagnosis.

You may qualify if:

• Patients meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with less than 5 years of evolution of the disorder.
• Being an outpatient for at least 4 weeks before the study (clinical stability).
• No changes in the antipsychotic medication during the month before the study.
• Score less than 4 in the P1, P2 and P3 items of the PANSS.
• Score less than 4 in the Calgary Depression Scale.

You may not qualify if:

• Intellectual disability (IQ\<70).
• History of brain damage.
• History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.
• PARTICIPANTS WITHOUT SCHIZOPHRENIA
• Healthy people over 18 years old.
• Sensory impairment: visual or hearing disabilities.
• Intellectual disability (IQ\<70).
• History of neurologic disease.
• History of psychiatric disorder.
• History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (8)

• Abu-Akel A, Bo S. Superior mentalizing abilities of female patients with schizophrenia. Psychiatry Res. 2013 Dec 30;210(3):794-9. doi: 10.1016/j.psychres.2013.09.013. Epub 2013 Oct 5.

  PMID: 24103909 BACKGROUND

• Bora E, Pantelis C. Theory of mind impairments in first-episode psychosis, individuals at ultra-high risk for psychosis and in first-degree relatives of schizophrenia: systematic review and meta-analysis. Schizophr Res. 2013 Mar;144(1-3):31-6. doi: 10.1016/j.schres.2012.12.013. Epub 2013 Jan 21.

  PMID: 23347949 BACKGROUND

• Bozikas VP, Andreou C. Longitudinal studies of cognition in first episode psychosis: a systematic review of the literature. Aust N Z J Psychiatry. 2011 Feb;45(2):93-108. doi: 10.3109/00048674.2010.541418.

  PMID: 21320033 BACKGROUND

• Green MF, Penn DL, Bentall R, Carpenter WT, Gaebel W, Gur RC, Kring AM, Park S, Silverstein SM, Heinssen R. Social cognition in schizophrenia: an NIMH workshop on definitions, assessment, and research opportunities. Schizophr Bull. 2008 Nov;34(6):1211-20. doi: 10.1093/schbul/sbm145. Epub 2008 Jan 8.

  PMID: 18184635 BACKGROUND

• Kohler CG, Turner TH, Bilker WB, Brensinger CM, Siegel SJ, Kanes SJ, Gur RE, Gur RC. Facial emotion recognition in schizophrenia: intensity effects and error pattern. Am J Psychiatry. 2003 Oct;160(10):1768-74. doi: 10.1176/appi.ajp.160.10.1768.

  PMID: 14514489 BACKGROUND

• Mesholam-Gately RI, Giuliano AJ, Goff KP, Faraone SV, Seidman LJ. Neurocognition in first-episode schizophrenia: a meta-analytic review. Neuropsychology. 2009 May;23(3):315-36. doi: 10.1037/a0014708.

  PMID: 19413446 BACKGROUND

• Savla GN, Vella L, Armstrong CC, Penn DL, Twamley EW. Deficits in domains of social cognition in schizophrenia: a meta-analysis of the empirical evidence. Schizophr Bull. 2013 Sep;39(5):979-92. doi: 10.1093/schbul/sbs080. Epub 2012 Sep 4.

  PMID: 22949733 BACKGROUND

• Navarra-Ventura G, Fernandez-Gonzalo S, Turon M, Pousa E, Palao D, Cardoner N, Jodar M. Gender Differences in Social Cognition: A Cross-Sectional Pilot Study of Recently Diagnosed Patients with Schizophrenia and Healthy Subjects. Can J Psychiatry. 2018 Aug;63(8):538-546. doi: 10.1177/0706743717746661. Epub 2017 Dec 7.

  PMID: 29216439 DERIVED

MeSH Terms

Interventions

Sex

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Sol Fernandez-Gonzalo, PhD

  Corporació Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist researcher

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 14, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

ES (1)