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

Cognitive Impairments Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053204
• Other study ID #: PWRq2021-59
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: Jun Chen, M.D., Ph.D
• Phone: 021-34773367
• Email: doctorcj2010[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognitive Dysfunction
• Cognitive Impairments

Locations

Country	Name	City	State
China	Shanghai Mental Health Center IRB	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 week
Secondary	HAMD-17	Assess the state of depression	up to 12 week
Secondary	HAM-A	Assessing anxiety state	up to 12 week
Secondary	Pittsburgh Sleep Quality Index,PSQI	Evaluate sleep quality	up to 12 week