Influence Factors and Cognitive Characteristics in Unipolar and Bipolar Depression:Based on the THINC-it Tool
NCT ID: NCT05053204
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2021-05-15
2023-06-30
Brief Summary
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Detailed Description
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This study includes three steps.
1. baseline: demographic data, theTHINC-it tool , clinical scales（HAMD-17,HAMA、YMRS、PSQI） evaluation and Laboratory examination（blood glucose, blood lipids, BMI）
2. follow-up (4 week): Clinical scales and THINC-it tool were evaluated in unipolar and bipolar depression.
3. follow-up (12 weeks): all patients with bipolar depression were evaluated by clinical scales, THINC-it test.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Interventions
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Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
2. Any drugs that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers.
3. Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it tool.
4. The patients have some serious physical conditions.
5. The patients received electroconvulsive therapy ((ECT)) in the past 6 months.
6. They are serious negative suicidal concepts and behaviors.
18 Years
60 Years
ALL
Yes
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Jun Chen, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center
Locations
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Shanghai Mental Health Center IRB
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PWRq2021-59
Identifier Type: -
Identifier Source: org_study_id
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