SchizophreniaNCT06278532
Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS
An observational study of Schizophrenia and Negative Symptoms in Schizophrenia, run by Lithuanian University of Health Sciences at 2 sites in Lithuania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Negative Symptoms in Schizophrenia, Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis)
- What is being tested?
- Brief Negative Symptoms Scale, The Calgary Depression Scale for Schizophrenia and The Schizophrenia Cognition Rating Scale
- How many people
- 200 participants
- Where
- 2 sitesLithuania
- Study dates
- 11 Dec 2023to 11 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Inpatients between 18 and 65 years old with a diagnosis of F20, F25, or F21, according to ICD-10, who sign the informed consent form and do not have any exclusion criteria, will be included in the study. We will not devide patients who have active psychotic symptoms and those who do not.
Who may be able to join
- age 18 - 65 years old;
- Diagnosis of F20, F25 or F21 according to ICD-10;
- Signed informed consent form.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania2 sites, 2 recruiting
- Recruiting
Lithuanian University of Health Sciences Hospital Kaunas Clinics
Kaunas, LT-50161
Jonas Montvidas, +37066240919, jonas.montvidas@lsmu.lt
Eimantas Zauka, +37069220076, eimantas.zauka@kaunoklinikos.lt
- Recruiting
Jonas Montvidas
Kaunas, LT-53137
Jonas Montvidas, +37066240919, jonas.montvidas@lsmu.lt
Algirdas Musneckis, +37061378748, algirdas.musneckis@kaunoklinikos.lt
About this study
Official title: Validation of the Lithuanian Version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and the Schizophrenia Cognition Rating Scale
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.
Read the detailed description
This scale validation study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale Schizophrenia Cognition Rating Scale in the Lithuanian sample. The main aim of this study is:
- to evaluate the convergent and discriminant validity of Lithuanian versions of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.
Participants will be evaluated using the Positive and Negative Symptoms Scale (PANSS), Montgomery Asberg Depression Rating Scale (MADRS), Montreal Cognitive Assessment (MoCA) test, Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.
To discern the discriminant validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to results from the positive and general subscale of the Positive and Negative Symptoms Scale and the Montgomery Asperger Depression Rating Scale. To discern the convergent validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to the results from the negative subscale of the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale.
To discern the discriminant validity of the Calgary Depression Scale for Schizophrenia for depressive symptoms of schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale. To check the convergent validity of the Calgary Depression Scale for Schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Montgomery Asperger Depression Rating Scale.
Finally, to check the discriminant validity of the Schizophrenia Cognition Rating Scale, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montgomery Asperger Depression Rating Scale and the Positive and Negative Symptoms Scale. In contrast, to prevent convergent validity, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montreal Cognitive Assessment test.
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia, Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis), Cognitive Deficit
- Being tested
- Brief Negative Symptoms Scale, The Calgary Depression Scale for Schizophrenia, The Schizophrenia Cognition Rating Scale
- Keywords
- Schizophrenia, Negative symptoms, Depressive symptoms of Schizophrenia, Cognitive deficits of Schizophrenia
- Medical subject headings
- Schizophrenia, Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negative Symptoms ScaleDiagnostic test
Also called BNSS
The Lithuanian Brief Negative Symptoms scale (BNSS) version will be used and validated. BNSS is used as a modern tool for the evaluation of negative symptoms of schizophrenia. Older tools used for negative symptoms evaluation often include symptoms from other dimensions of symptoms of schizophrenia, and BNSS evaluates negative symptoms specifically. BNSS is a semi-structured interview made of 13 items. There are six subscales: anhedonia (3 items), lack of normal distress (1 item), asociality (2 items), avolition (2 items), blunted affect (3 items) and alogia (2 items).
The Calgary Depression Scale for SchizophreniaDiagnostic test
Also called CDSS
The Lithuanian version of the CDSS will be used and validated. CDSS is a tool used to evaluate depressive symptoms, specifically for patients with schizophrenia. Often, distinguishing between depressive and negative symptoms of schizophrenia is difficult. Therefore, it is recommended to use tools designed specifically for patients with schizophrenia. CDSS is the only depression scale designed to assess depression in people with a schizophrenia syndrome disorder. It is a semi-structured interview consisting of 9 items.
The Schizophrenia Cognition Rating ScaleDiagnostic test
Also called SCoRS
The Lithuanian version of the SCoRS will be used and validated. SCoRS is a 20-item interview-based assessment tool that evaluates cognitive deficits and the degree to which these deficits impair specifically in patients with schizophrenia.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start11 Dec 2023
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginija Adomaitienė, Lithuanian University of Health Sciences
- Investigators
- Virginija Adomaitienė, Prof., Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278532
- Sponsor's protocol ID
- NEGKOG
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20558531Keefe 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.
PubMed 25028065Muller 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.
PubMed 16040126
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Lithuanian Version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and the Schizophrenia Cognition Rating Scale
- ClinicalTrials.gov ID
- NCT06278532
- Acronym / sponsor ID
- NEGKOG
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia, Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis), Cognitive Deficit
- Keywords
- Schizophrenia, Negative symptoms, Depressive symptoms of Schizophrenia, Cognitive deficits of Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This scale validation study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale Schizophrenia Cognition Rating Scale in the Lithuanian sample. The main aim of this study is:
- to evaluate the convergent and discriminant validity of Lithuanian versions of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.
Participants will be evaluated using the Positive and Negative Symptoms Scale (PANSS), Montgomery Asberg Depression Rating Scale (MADRS), Montreal Cognitive Assessment (MoCA) test, Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale.
To discern the discriminant validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to results from the positive and general subscale of the Positive and Negative Symptoms Scale and the Montgomery Asperger Depression Rating Scale. To discern the convergent validity of the Brief Negative Symptoms Scale for negative symptoms, results from the Brief Negative Symptoms Scale will be compared to the results from the negative subscale of the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale.
To discern the discriminant validity of the Calgary Depression Scale for Schizophrenia for depressive symptoms of schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Positive and Negative Symptoms Scale and the Self-evaluation of Negative Symptoms scale. To check the convergent validity of the Calgary Depression Scale for Schizophrenia, results obtained from the Calgary Depression Scale for Schizophrenia will be compared to results obtained from the Montgomery Asperger Depression Rating Scale.
Finally, to check the discriminant validity of the Schizophrenia Cognition Rating Scale, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montgomery Asperger Depression Rating Scale and the Positive and Negative Symptoms Scale. In contrast, to prevent convergent validity, results obtained from the Schizophrenia Cognition Rating Scale will be compared to results obtained from the Montreal Cognitive Assessment test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Inpatients between 18 and 65 years old with a diagnosis of F20, F25, or F21, according to ICD-10, who sign the informed consent form and do not have any exclusion criteria, will be included in the study. We will not devide patients who have active psychotic symptoms and those who do not.
Key inclusion criteria (3 listed)
- age 18 - 65 years old;
- Diagnosis of F20, F25 or F21 according to ICD-10;
- Signed informed consent form.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Negative Symptoms ScaleAlso: BNSSThe Lithuanian Brief Negative Symptoms scale (BNSS) version will be used and validated. BNSS is used as a modern tool for the evaluation of negative symptoms of schizophrenia. Older tools used for negative symptoms evaluation often include symptoms from other dimensions of symptoms of schizophrenia, and BNSS evaluates negative symptoms specifically. BNSS is a semi-structured interview made of 13 items. There are six subscales: anhedonia (3 items), lack of normal distress (1 item), asociality (2 items), avolition (2 items), blunted affect (3 items) and alogia (2 items). | Diagnostic test | – |
| The Calgary Depression Scale for SchizophreniaAlso: CDSSThe Lithuanian version of the CDSS will be used and validated. CDSS is a tool used to evaluate depressive symptoms, specifically for patients with schizophrenia. Often, distinguishing between depressive and negative symptoms of schizophrenia is difficult. Therefore, it is recommended to use tools designed specifically for patients with schizophrenia. CDSS is the only depression scale designed to assess depression in people with a schizophrenia syndrome disorder. It is a semi-structured interview consisting of 9 items. | Diagnostic test | – |
| The Schizophrenia Cognition Rating ScaleAlso: SCoRSThe Lithuanian version of the SCoRS will be used and validated. SCoRS is a 20-item interview-based assessment tool that evaluates cognitive deficits and the degree to which these deficits impair specifically in patients with schizophrenia. | Diagnostic test | – |
Primary outcome
Validated Lithuanian version of the Brief Negative Symptoms Scale.
Time frame: Day 1
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.
Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia.
Time frame: Day 1
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.
Validated Lithuanian version of the Schizophrenia Cognition Rating Scale.
Time frame: Day 1
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.
3 secondary outcomes
Correlation between negative symptoms and cognitive deficits of schizophrenia
Time frame: Day 1
Correlation between depressive symptoms and cognitive deficits of schizophrenia
Time frame: Day 1
Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 20558531Kirkpatrick 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.
- Background: PubMed 25028065Keefe 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.
- Background: PubMed 16040126Muller 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginija Adomaitienė, Prof. principal investigator
Lithuanian University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Negative Symptoms in Schizophrenia, run by Lithuanian University of Health Sciences at 2 sites in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Montvidas, MD (+37066240919, jonas.montvidas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated Lithuanian version of the Brief Negative Symptoms Scale. (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278532, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.