Efficacy, safety and compliance of integrated traditional Chinese and Western medicine in patients with depression in the community: a multi-center, randomized controlled study

Phase 4

• Conditions: Major depressive disorder

• Registration Number: ITMCTR2100004371
• Lead Sponsor: Shandong Mental Health Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients in the community;
2. Patients who met the ICD-10 diagnostic criteria for depressive disorder (F32 depressive episode or f33 recurrent depressive disorder);
3. Patients aged 18-65, male or female;
4. Subjects with 17 or more HAMD scores at baseline;
5. Informed consent signed by the patient or his legal guardian;

Exclusion Criteria

1. Patients with serious suicidal tendency;
2. Patients with psychotic symptoms such as hallucination and delusion;
3. Patients with serious or unstable heart, liver, kidney, endocrine, blood and other internal diseases;
4. Patients with history of epilepsy;
5. Patients with diagnosis of alcohol and drug dependence within one year;
6. Patients with depression secondary to other mental or physical diseases;
7. Women who are lactating, pregnant or likely to be pregnant during the trial;
8. Patients currently using antidepressants;
9. Patients who failed to use SSRIs antidepressants in the past;
10. Patients without supervision or unable to take medicine according to doctor's advice;
11. Patients with bipolar disorder.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morisky Medication Adherence Scale;TDM;Clinical Global Impression;Hamilton Depression Scale;Hamilton Anxiety Scale;Montgomery Asberg depression rating scale;Treatment Emergent Symptom Scale;