Influence Factors and Cognitive Characteristics in Unipolar and Bipolar Depression:Based on the THINC-it Tool

• Conditions: Cognitive Impairments

• Registration Number: NCT05053204
• Lead Sponsor: Shanghai Mental Health Center

Brief 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 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.

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.

Study Timeline

• Study Start: 2021-05-15
• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14
• Primary Completion: 2022-10-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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.

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

1. Current alcohol and / or substance use disorders.
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the THINC-it Tool	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.

Secondary Outcome Measures

Name	Time	Method
HAM-A	up to 12 week	Assessing anxiety state
Pittsburgh Sleep Quality Index，PSQI	up to 12 week	Evaluate sleep quality
HAMD-17	up to 12 week	Assess the state of depression

Trial Locations

Locations (1)

Shanghai Mental Health Center IRB; 🇨🇳 Shanghai, Shanghai, China