Schizophrenia Clinical Trial
Official title:
Validation of the Lithuanian Version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and the Schizophrenia Cognition Rating Scale
NCT number | NCT06278532 |
Other study ID # | NEGKOG |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 11, 2023 |
Est. completion date | December 11, 2026 |
This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 11, 2026 |
Est. primary completion date | December 11, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - age 18 - 65 years old; - Diagnosis of F20, F25 or F21 according to ICD-10; - Signed informed consent form. Exclusion Criteria: - Age younger than 18 or older than 65 years old; - Did not sign the informed consent form; - Legally inactive person - Patients with a comorbid or primary diagnosis of mental retardation according to ICD-10 (F70 - F79); - Patients with a comorbid or primary diagnosis of mental and behavioural disorders due to psychoactive substance use (F10 - F19) - Patients with a comorbid of primary diagnosis of organic, including symptomatic, mental disorders (F00 - F09) |
Country | Name | City | State |
---|---|---|---|
Lithuania | Jonas Montvidas | Kaunas | |
Lithuania | Lithuanian University of Health Sciences Hospital Kaunas Clinics | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian University of Health Sciences |
Lithuania,
Keefe RS, Davis VG, Spagnola NB, Hilt D, Dgetluck N, Ruse S, Patterson TD, Narasimhan M, Harvey PD. Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale. Eur Neuropsychopharmacol. 2015 Feb;25(2):176-84. doi: 10.1016/j.euroneuro.2014.06.009. Epub 2014 Jun 28. — View Citation
Kirkpatrick B, Strauss GP, Nguyen L, Fischer BA, Daniel DG, Cienfuegos A, Marder SR. The brief negative symptom scale: psychometric properties. Schizophr Bull. 2011 Mar;37(2):300-5. doi: 10.1093/schbul/sbq059. Epub 2010 Jun 17. — View Citation
Muller MJ, Brening H, Gensch C, Klinga J, Kienzle B, Muller KM. The Calgary Depression Rating Scale for schizophrenia in a healthy control group: psychometric properties and reference values. J Affect Disord. 2005 Sep;88(1):69-74. doi: 10.1016/j.jad.2005.04.005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validated Lithuanian version of the Brief Negative Symptoms Scale. | Patients will be evaluated using the Lithuanian version of the Brief Negative Symptoms Scale (score 0 - 78; a greater score means more pronounced negative symptoms) once during the inpatient treatment. The results will be compared with the Positive and Negative Symptoms Scale score (0 - 210; a greater score means more pronounced symptoms of schizophrenia), Montgomery Asperger Depression Scale (Score 0 - 60; a greater score means greater symptoms of depression), Self-evaluation of Negative Symptoms Scale (score 0 - 40; greater score means more pronounced negative symptoms), and Montreal Cognitive Assessment Test (score 0 - 31; a greater score means better cognitive functions). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations. | Day 1 | |
Primary | Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia. | Patients will be evaluated using the Lithuanian version of the Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression) once during the inpatient treatment, and the results will be compared with results from the Positive and Negative Symptoms Scale (score 0 - 210, greater score means more pronounced symptoms of schizophrenia), Montgomery Asperger Depression Scale (Score 0 - 60; greater score means greater symptoms of depression), and Self-evaluation of Negative Symptoms Scale (score 0 - 40; greater score means more pronounced negative symptoms). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations. | Day 1 | |
Primary | Validated Lithuanian version of the Schizophrenia Cognition Rating Scale. | Patients will be evaluated using the Lithuanian version of the Schizophrenia Cognition Rating Scale (score 0 - 80; a greater score means worse cognitive functions; global functioning score 1 - 10 with a greater score meaning worse functioning) once during the inpatient treatment, and the results will be compared with results from the Montreal Cognitive Assessment Test (score 0 - 31; a greater score means better cognitive functions). Convergent and divergent validities will be calculated for each validated instrument by calculating correlations. | Day 1 | |
Secondary | Correlation between negative symptoms and cognitive deficits of schizophrenia | Correlation between negative symptoms evaluated with second-generation negative symptoms assessment tools (Brief Negative Symptoms Scale (score 0 - 78; a greater score means more pronounced negative symptoms) and Self-evaluation of Negative Symptoms scale (score 0 - 40; greater score means more pronounced negative symptoms) and Schizophrenia Cognition Rating Scale (score 0 - 80; a greater score means worse cognitive functions; global functioning score 1 - 10 with a greater score meaning worse functioning). Correlations between specific subscales of the Brief Negative Symptoms Scale, the Self-evaluation of Negative Symptoms Scale, and the Schizophrenia Cognition Rating Scale will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes. | Day 1 | |
Secondary | Correlation between depressive symptoms and cognitive deficits of schizophrenia | Correlation between depressive symptoms evaluated with the Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression) and Schizophrenia Cognition Rating Scale (score 0 - 80; a greater score means worse cognitive functions; global functioning score 1 - 10 with a greater score meaning worse functioning). Correlations between specific items of the Calgary Depression Scale for Schizophrenia and the Schizophrenia Cognition Rating Scale will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes. | Day 1 | |
Secondary | Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life | Correlation between results obtained from the Brief Negative Symptoms Scale score 0 - 78; a greater score means more pronounced negative symptoms), Self-evaluation of Negative Symptoms Scale (score 0 - 40; a greater score means more pronounced negative symptoms), Calgary Depression Scale for Schizophrenia (score 0 - 27; a greater score means greater depression), and the Schizophrenia Cognition Rating Scale (score 0 - 80; a greater score means worse cognitive functions; global functioning score 1 - 10 with a greater score meaning worse functioning) with results about the health-related quality of life of patients with schizophrenia evaluated with the 36-Item Short Form Survey (8 subscores scored from 0 percent to 100 percent, with more percents meaning better health-related quality of life) will be calculated. We will check for differences in correlation between different ages, education, duration of disease groups, and sexes. | Day 1 |
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