DepressionNCT01590784
Reliability and Validity of Thai Calgary Depression Scale of Schizophrenia (CDSS)
An observational study of Depression, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Depression in patients with schizophrenia is common. Several factors was found to be associated with depression including medical illness, quality of life, positive symptoms, and typical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depression
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pariticipants diagnosed with schizophrenia according to DSM-IV-TR.
Who may be able to join
- Aged 18 years or over
- Diagnosis of schizophrenia according to DSM-IV-TR
Who cannot join
- Having organic brain syndrome
- Not fluent in Thai
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability and Validity of the Thai Version of Calgary Depression Scale for Schizophrenia (CDSS)
Depression in patients with schizophrenia is common. Several factors was found to be associated with depression including medical illness, quality of life, positive symptoms, and typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used for screening depression in schizophrenia,however; the Thai version of CDSS has not been validated.
This study aims to a.) test the reliability and validity of the Thai version of Calgary depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors associated with depression in patients with schizophrenia including quality of life, type of antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the Faculty of Medicine, Chiang Mai University, Thailand.
Read the detailed description
Measurements:
The Thai version of Calgary depression scale of schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Asberg Depression Rating Scale (MADRS), the Thai abbreviated version of World Health Organization quality of life (WHOQOL-BREF-THAI).
- Conditions
- Depression
- Keywords
- Depression, Schizophrenia
- Medical subject headings
- Depression, Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
The reliability of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
The inter-rater reliability, the test-retest reliability will be analyzed.
Measured: 3 months
The validity of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
The Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Åsberg Depression Rating Scale (MADRS) will be administered by the first rater, whereas the CDSS will be assessed by a second independent rater.
Measured: 3 months
Secondary outcomes (4)
The prevalence of depression in patients with schizophrenia
The point prevalence of depression in patients with schizophrenia will be presented in percentage.
Measured: 3 months
The association between depression in schizophrenia and quality of life.
The association between depression in schizophrenia and quality of life (WHOQOL-BREF-THAI).
Measured: 3 months
The association between depression in schizophrenia and type of antipsychotic drugs.
The association between depression in schizophrenia and type of antipsychotic drugs (typical vs atypical).
Measured: 3 months
The association between depression in schizophrenia and severity of schizophrenia.
The association between depression in schizophrenia and severity of schizophrenia (PANSS score).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirijit Suttajit, Chiang Mai University
- Investigators
- Sirijit Suttajit, MD, MSc, Study director, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590784
- Sponsor's protocol ID
- PSY-11-09-09-12
- Status last verified
- Jul 2016
- First submitted
- 27 Apr 2012
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Thai Version of Calgary Depression Scale for Schizophrenia (CDSS)
- ClinicalTrials.gov ID
- NCT01590784
- Acronym / sponsor ID
- PSY-11-09-09-12
- Conditions
- Depression
- Keywords
- Depression, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- 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.
Depression in patients with schizophrenia is common. Several factors was found to be associated with depression including medical illness, quality of life, positive symptoms, and typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used for screening depression in schizophrenia,however; the Thai version of CDSS has not been validated.
This study aims to a.) test the reliability and validity of the Thai version of Calgary depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors associated with depression in patients with schizophrenia including quality of life, type of antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the Faculty of Medicine, Chiang Mai University, Thailand.
Detailed description
Measurements:
The Thai version of Calgary depression scale of schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Asberg Depression Rating Scale (MADRS), the Thai abbreviated version of World Health Organization quality of life (WHOQOL-BREF-THAI).
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pariticipants diagnosed with schizophrenia according to DSM-IV-TR.
Key inclusion criteria (2 listed)
- Aged 18 years or over
- Diagnosis of schizophrenia according to DSM-IV-TR
Key exclusion criteria (2 listed)
- Having organic brain syndrome
- Not fluent in Thai
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The reliability of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
Time frame: 3 months
The inter-rater reliability, the test-retest reliability will be analyzed.
The validity of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients.
Time frame: 3 months
The Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Åsberg Depression Rating Scale (MADRS) will be administered by the first rater, whereas the CDSS will be assessed by a second independent rater.
4 secondary outcomes
The prevalence of depression in patients with schizophrenia
Time frame: 3 months
The association between depression in schizophrenia and quality of life.
Time frame: 3 months
The association between depression in schizophrenia and type of antipsychotic drugs.
Time frame: 3 months
The association between depression in schizophrenia and severity of schizophrenia.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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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. This study is not recruiting at the moment.
Sirijit Suttajit, MD, MSc study director
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Chiang Mai University at 1 site in Thailand.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reliability of the Thai version of the Calgary Depression Scale for Schizophrenia (CDSS) in schizophrenia patients. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2016.