Last updated: April 19, 2024
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Depression
Depression (Adult And Geriatric)
Affective Disorders
Treatment
N/AClinical Study ID
NCT04518592
MDSDOT
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subjects aged 18-65 years, outpatients or inpatients.
- Meets the DSM-V criteria for Severe Major Depressive Disorder ; a singleepisode(296.21、296.22、296.23)or recurrent episode (296.31、296.32、296.33);
- MADRS score greater than or equal to 24 in baseline;
- HAMD-17 score greater than or equal to 20 in baseline.
- Patients have learned and voluntarily participated in the study, and have to signinformed consent.
Exclusion
Exclusion Criteria:
- Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and otherpsychotic disorders, bipolar and related disorders, anxiety disorders,obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ).
- Patient has survived suicide attempt , or may have a significant risk for suicidalbehavior ,or with a score of >3 on suicidal thoughts item 10 on the MADRS.
- Depressive episode of an organic mental disorder secondary to a systemic disease or acentral nervous system disease, such as depressive episode secondary tohypothyroidism.
- Serious and instable body disease such as cerebrovascular disease, respiratorydisease, blood disease, liver and kidney disease, disease of internal secretion,nervous system and other systemic disease.
- any history of seizures or other organic brain diseases.
- History of alcohol or drug abuse (besides nicotine) over the last 6 months
- Serious and instable body disease such as cerebrovascular disease, liver and kidneydisease, disease of internal secretion (abnormal thyroid function), blood disease; anyhistory of seizures or other organic brain diseases.
- Subjects who can't take drug or have an operation history which affect drugmetabolism.
- Clinically significant changes in ECG or laboratory tests, including >1.5X upper limitof normal liver function、over the limit of normal renal function and bloodsugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
- Pregnant or lactating women and women of childbearing potential throughout the studyperiod; men who have the desire of fertility within three months;
- Participation in other clinical studies in the nearly 1 month before screen.
- Other conditions which, in the investigator's judgment, render patients unsuitable forthe clinical study.
Study Design
Total Participants: 300
Study Start date:
December 22, 2020
Estimated Completion Date:
September 30, 2024
Study Description
Connect with a study center
Shanghai Mental Health Center
Shanghai, Shanghai 200030
ChinaActive - Recruiting
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