Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05053204
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05053204
Study Brief:
Protocol Section:
NCT05053204