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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT05481957
Eligibility Criteria:
Inclusion Criteria:
1. BMI between \>18.5 and \<29.5 kg
2. The MINI-International Neuropsychiatric Interview is adopted and patients selected shall meet the clinical diagnostic criteria stipulated in DSM-5 on clinical diagnostic criteria for type II bipolar depression.
3. HDRS17\>17
4. YMRS score \<5;
5. No treatment was given before enrollment;
6. All patients and their family members were informed and agreed to this trial.
Exclusion Criteria:
1. Those who suffering from other severe mental diseases;
2. Those who suffering from severe somatic diseases;
3. Those who had received medication (such as anti-depressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
4. Those who had been treated with ECT one month before enrollment;
5. Those who currently have severe suicidal thoughts or behavior, or who are extremely excited and fail to cooperate with;
6. Women in pregnancy and lactation;
7. Patients with contraindications to drugs used in this trial;
8. Those who have participated in a clinical trial of an investigational product in the last 60 days
10\) Substance misuse/abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
45 Years
Study:
NCT05481957
Study Brief:
Protocol Section:
NCT05481957