Schizophrenia Clinical Trial
Official title:
Analysis of the Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through fMRI Techniques
Verified date | February 2011 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying cognitive improvement is not well understood. The aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.
Status | Completed |
Enrollment | 45 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1. - Presence of cognitive deficit confirmed by the neuropsychological battery. - Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment. Exclusion Criteria: - Presence of organic-cerebral affectation due to neurological or traumatic conditions - Abuse of psychotropic substances - Presence of other psychiatric symptomatology |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Centro de Investigación Biomédica en Red de Salud Mental, University of Barcelona |
Spain,
Penadés R, Pujol N, Catalán R, Masana G, García-Rizo C, Bargalló N, González-Rodríguez A, Vidal-Piñeiro D, Bernardo M, Junqué C. Cortical thickness in regions of frontal and temporal lobes is associated with responsiveness to cognitive remediation therapy in schizophrenia. Schizophr Res. 2016 Mar;171(1-3):110-6. doi: 10.1016/j.schres.2016.01.006. Epub 2016 Jan 15. — View Citation
Penadés R, Pujol N, Catalán R, Massana G, Rametti G, García-Rizo C, Bargalló N, Gastó C, Bernardo M, Junqué C. Brain effects of cognitive remediation therapy in schizophrenia: a structural and functional neuroimaging study. Biol Psychiatry. 2013 May 15;73(10):1015-23. doi: 10.1016/j.biopsych.2013.01.017. Epub 2013 Feb 26. Erratum in: Biol Psychiatry. 2014 Mar 1;75(5):425. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fMRI patterns of connectivity | Scores on Fractional Anisotropy (FA) index from the Diffusor Technique Images (DTI) and Tract Based Spatial Statistics (TBSS) analyses. Also, scores in the Independent Component Analysis (ICA). | Change from baseline in Fractional Anisotropy an Independent Component Analisys indexes at 16 weeks | No |
Secondary | Symptoms | Scores on Positive and Negative Syndromes Scale (PANSS) | Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks | No |
Secondary | Social Functioning | Score on Social Functioning Scale (SFS) | Change from baseline in scores of Social Functioning Scale at time 16 weeks | No |
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