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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004371
Enrollment
Unknown
Registered
2021-02-03
Start date
2021-02-05
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactGuanglei Xun

Shandong Mental Health Center

xungl@163.com+86 15069053599

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026