Bipolar DepressionNCT04471454
Verification of the Reliability and Validity of THINC-it Tool in Bipolar Depression
An observational study of Bipolar Depression, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2020to 30 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bipolar depression group: samples were collected from outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New area Mental Health Center from January 2020 to December 2020, who met the diagnostic criteria of DSM-5. Healthy control group: the sample came from the social recruitment of healthy people who met the criteria of the control group and matched in sex, age and education level. 100 cases were planned to be included in the group.
Who may be able to join
- Case group:
- Participants in psychiatric outpatients and inpatients are able and willing to provide informed consent.
- two。. The participants were male or female aged between 18 and 65, with junior high school education or above.
- 3. According to DSM-5 criteria, participants were diagnosed with depressive episodes of bipolar disorder.
- 4. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5.
- 5. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants.
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- 6. The combination or use of supportive psychotherapy is allowed.
- Control group:
- 1.it did not meet any of the diagnostic criteria of axis I in DSM-5 in the past or at present.
- 2.18-65 years old, junior high school education or above. 3.have sufficient audio-visual skills to complete the necessary examinations of the study.
- 4.Willing to participate in this study, and the informed consent form was signed by the subjects.
Who cannot join
- Current alcohol and / or substance use disorders.
- Any drug that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers.
- Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it cognitive test.
- The patient has some serious physical conditions.
- The patient received electroconvulsive therapy ((ECT)) in the past 6 months.
- There are serious negative suicidal concepts and behaviors.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center IRB
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Verification of the Reliability and Validity of THINC-it Cognitive Test in the Assessment of Cognitive Impairment in Bipolar Depression
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear. The purpose of this study is to verify the reliability and validity of THINC-it cognitive test in bipolar depression, and to further explore the difference of cognitive impairment between attack and remission of bipolar depression, so as to provide empirical research basis for clinical evaluation-based treatment.
Read the detailed description
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear.
This study includes three steps.
- baseline: demographic data, sequential test THINC-it and standard test tools, clinical scale evaluation, to verify the discriminant validity and parallel validity of THINC-it in bipolar depression.
- follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in bipolar depression.
- follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical scale, THINC-it test, longitudinal comparison data, and the influencing factors of cognitive impairment were analyzed.
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, cognitive impairment, THINC-it
- Medical subject headings
- Bipolar Disorder, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite THINC-it Tool Score
The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
Measured: up to 8 week
CANTAB reaction time (RTI)
online computer test, RTI evaluates the response speed of movement and psychology, as well as activity time, reaction time, accurate value and error value of response, and calculates the time required to correctly evaluate the occurrence of stimuli in one location.
Measured: Up to 1 week
1-back memory task (1-back)
the subjects' attention, memory, reaction speed and executive function were tested.
Measured: Up to 1 week
Digit Symbol Substitution Test (DSST)
participants in the digital symbol substitution test calculated the correct total number by matching symbols and numbers as soon as possible within 90 seconds according to the coding table.
Measured: Up to 1 week
Trail Making Test B
he subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.
Measured: Up to 1 week
Secondary outcomes (3)
Sheehan Disability scale (SDS)
Evaluation of the severity of overall functional impairment
Measured: Up to 8 week
HAM-D
Assess the state of depression
Measured: Up to 8 week
HAM-A
Assessing anxiety state
Measured: Up to 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start5 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D., Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471454
- Sponsor's protocol ID
- 2020-03
- Status last verified
- Aug 2021
- First submitted
- 12 Jul 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Reliability and Validity of THINC-it Cognitive Test in the Assessment of Cognitive Impairment in Bipolar Depression
- ClinicalTrials.gov ID
- NCT04471454
- Acronym / sponsor ID
- 2020-03
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, cognitive impairment, THINC-it
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Jul 2020 (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.
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear. The purpose of this study is to verify the reliability and validity of THINC-it cognitive test in bipolar depression, and to further explore the difference of cognitive impairment between attack and remission of bipolar depression, so as to provide empirical research basis for clinical evaluation-based treatment.
Detailed description
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear.
This study includes three steps.
- baseline: demographic data, sequential test THINC-it and standard test tools, clinical scale evaluation, to verify the discriminant validity and parallel validity of THINC-it in bipolar depression.
- follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in bipolar depression.
- follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical scale, THINC-it test, longitudinal comparison data, and the influencing factors of cognitive impairment were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar depression group: samples were collected from outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New area Mental Health Center from January 2020 to December 2020, who met the diagnostic criteria of DSM-5. Healthy control group: the sample came from the social recruitment of healthy people who met the criteria of the control group and matched in sex, age and education level. 100 cases were planned to be included in the group.
Key inclusion criteria (11 listed)
- Case group:
- two。. The participants were male or female aged between 18 and 65, with junior high school education or above.
- 3. According to DSM-5 criteria, participants were diagnosed with depressive episodes of bipolar disorder.
- 4. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5.
- 5. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants.
Key exclusion criteria (6 listed)
- Current alcohol and / or substance use disorders.
- Any drug that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers.
- Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it cognitive test.
- The patient has some serious physical conditions.
- The patient received electroconvulsive therapy ((ECT)) in the past 6 months.
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
Composite THINC-it Tool Score
Time frame: up to 8 week
The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
CANTAB reaction time (RTI)
Time frame: Up to 1 week
online computer test, RTI evaluates the response speed of movement and psychology, as well as activity time, reaction time, accurate value and error value of response, and calculates the time required to correctly evaluate the occurrence of stimuli in one location.
1-back memory task (1-back)
Time frame: Up to 1 week
the subjects' attention, memory, reaction speed and executive function were tested.
Digit Symbol Substitution Test (DSST)
Time frame: Up to 1 week
participants in the digital symbol substitution test calculated the correct total number by matching symbols and numbers as soon as possible within 90 seconds according to the coding table.
Trail Making Test B
Time frame: Up to 1 week
he subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.
3 secondary outcomes
Sheehan Disability scale (SDS)
Time frame: Up to 8 week
HAM-D
Time frame: Up to 8 week
HAM-A
Time frame: Up to 8 week
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 26 Oct 2021.
- 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. This study is not recruiting at the moment.
Jun Chen, M.D., Ph.D principal investigator
Shanghai Mental Health Center
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 Bipolar Depression, run by Shanghai Mental Health Center at 1 site in China.
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 11 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: finished, as of the sponsor's last update on 26 Oct 2021. 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 China. 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?
Composite THINC-it Tool Score (time frame: up to 8 week). The study lists 5 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 26 Oct 2021.