Cognitive ImpairmentsNCT05053204
Influence Factors and Cognitive Characteristics in Unipolar and Bipolar Depression:Based on the THINC-it Tool
An observational study of Cognitive Impairments, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Cognitive impairment is the core symptom of unipolar and bipolar depression, which seriously affects the prognosis of the disease and the rehabilitation of social function. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairments
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to 30 Jun 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: According to the diagnostic criteria of ICD-10 Unipolar and bipolar depressive disorder, 40 patients with Major depressive disorder, 40 patients with bipolar depression and 40 healthy controls matched with the sex, age and education level of the patients in the case group served as healthy controls.
Who may be able to join
- Case group:
- 1、Participants in psychiatric outpatients and inpatients are able and willing to provide informed consent.
- 2. The participants were male or female aged between 18 and 60, with junior high school education or above.
- 3. According to ICD-10 criteria, participants were diagnosed with Unipolar and bipolar depressive disorder.
- 4. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5 and HAMD-17 was greater than17.
- 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 in ICD-10 in the past or at present.
- 2.18-60 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 drugs 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 tool.
- The patients have some serious physical conditions.
- The patients received electroconvulsive therapy ((ECT)) in the past 6 months.
- They are serious negative suicidal concepts and behaviors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center IRB
Shanghai, Shanghai Municipality, 200030
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: Based on the THINC-it Tool to Explore the Characteristics and Related Factors of Cognitive Impairment in the Acute Stage of Unipolar and Bipolar Depression
Cognitive impairment is the core symptom of unipolar and bipolar depression, which seriously affects the prognosis of the disease and the rehabilitation of social function. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. In this study,the THINC-it tool was used to study the characteristics of cognitive impairment in unipolar and bipolar depression by longitudinal follow-up, which provides a theoretical basis for the differential diagnosis of unipolar and bipolar depression. Early identification and intervention of risk factors can improve the prognosis of the disease.
Read the detailed description
there is some cognitive impairment in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. The THINC-it is a simple, fast and free cognitive assessment tool for cognitive impairment screening of unipolar and bipolar depression.
This study includes three steps.
- baseline: demographic data, theTHINC-it tool , clinical scales（HAMD-17,HAMA、YMRS、PSQI） evaluation and Laboratory examination（blood glucose, blood lipids, BMI）
- follow-up (4 week): Clinical scales and THINC-it tool were evaluated in unipolar and bipolar depression.
- follow-up (12 weeks): all patients with bipolar depression were evaluated by clinical scales, THINC-it test.
- Conditions
- Cognitive Impairments
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| unipolar depression group | In accordance with the diagnostic criteria of ICD-10 Unipolar depressive disorder, outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area. | |
| bipolar depression group | In accordance with the diagnostic criteria of ICD-10 Bipolar depression , outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area. | |
| healthy control group | Any mental disorder that does not meet the diagnosis of ICD-10, and the society recruits healthy controls who match the sex, age and education level of the patients in the case-group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the THINC-it Tool
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 12 week
Secondary outcomes (3)
HAMD-17
Assess the state of depression
Measured: up to 12 week
HAM-A
Assessing anxiety state
Measured: up to 12 week
Pittsburgh Sleep Quality Index，PSQI
Evaluate sleep quality
Measured: up to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start15 May 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentsStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
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
- NCT05053204
- Sponsor's protocol ID
- PWRq2021-59
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on the THINC-it Tool to Explore the Characteristics and Related Factors of Cognitive Impairment in the Acute Stage of Unipolar and Bipolar Depression
- ClinicalTrials.gov ID
- NCT05053204
- Acronym / sponsor ID
- PWRq2021-59
- Conditions
- Cognitive Impairments
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Sep 2021 (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.
Cognitive impairment is the core symptom of unipolar and bipolar depression, which seriously affects the prognosis of the disease and the rehabilitation of social function. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. In this study,the THINC-it tool was used to study the characteristics of cognitive impairment in unipolar and bipolar depression by longitudinal follow-up, which provides a theoretical basis for the differential diagnosis of unipolar and bipolar depression. Early identification and intervention of risk factors can improve the prognosis of the disease.
Detailed description
there is some cognitive impairment in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. The THINC-it is a simple, fast and free cognitive assessment tool for cognitive impairment screening of unipolar and bipolar depression.
This study includes three steps.
- baseline: demographic data, theTHINC-it tool , clinical scales（HAMD-17,HAMA、YMRS、PSQI） evaluation and Laboratory examination（blood glucose, blood lipids, BMI）
- follow-up (4 week): Clinical scales and THINC-it tool were evaluated in unipolar and bipolar depression.
- follow-up (12 weeks): all patients with bipolar depression were evaluated by clinical scales, THINC-it test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unipolar depression group | – | –In accordance with the diagnostic criteria of ICD-10 Unipolar depressive disorder, outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area. |
| bipolar depression group | – | –In accordance with the diagnostic criteria of ICD-10 Bipolar depression , outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area. |
| healthy control group | – | –Any mental disorder that does not meet the diagnosis of ICD-10, and the society recruits healthy controls who match the sex, age and education level of the patients in the case-group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- According to the diagnostic criteria of ICD-10 Unipolar and bipolar depressive disorder, 40 patients with Major depressive disorder, 40 patients with bipolar depression and 40 healthy controls matched with the sex, age and education level of the patients in the case group served as healthy controls.
Key inclusion criteria (11 listed)
- 1、Participants in psychiatric outpatients and inpatients are able and willing to provide informed consent.
- 2. The participants were male or female aged between 18 and 60, with junior high school education or above.
- 3. According to ICD-10 criteria, participants were diagnosed with Unipolar and bipolar depressive disorder.
- 4. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5 and HAMD-17 was greater than17.
- 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 drugs 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 tool.
- The patients have some serious physical conditions.
- The patients 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | bipolar depression group, unipolar depression group |
Primary outcome
the THINC-it Tool
Time frame: up to 12 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.
3 secondary outcomes
HAMD-17
Time frame: up to 12 week
HAM-A
Time frame: up to 12 week
Pittsburgh Sleep Quality Index，PSQI
Time frame: up to 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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 Cognitive Impairments, 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D., Ph.D (021-34773367, doctorcj2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the THINC-it Tool (time frame: up to 12 week). 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 14 Sep 2022.