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

September 9, 2022 updated by: Shanghai Mental Health Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center IRB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HAMD-17
Time Frame: up to 12 week
Assess the state of depression
up to 12 week
HAM-A
Time Frame: up to 12 week
Assessing anxiety state
up to 12 week
Pittsburgh Sleep Quality Index，PSQI
Time Frame: up to 12 week
Evaluate sleep quality
up to 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWRq2021-59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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