generalized anxiety disorder (GAD)
Conditions
Interventions
Group 1:Duloxetine (60mg qd) + Jiuwei Zhenxin granules placebo
Group 2:Jiuwei Zhenxin granules (6g tid) + Duloxetine placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 44 Years
Inclusion criteria
Inclusion criteria: (1) Willing to participate in clinical research and signed the informed consent; (2) Age: 18-44 years old (according to the date of signing the informed consent), both male and female; (3) All the patients meet the diagnostic criteria of generalized anxiety disorder in the diagnostic and Statistical Manual of mental disorders - Fifth Edition (DSM-V); (4) HAMA anxiety scale score =7 and =21 points, in which anxious mood (item 1) score =2 points, depressive mood (item 6) score =3 points; Those who scored =17 points on HAMD depression scale were excluded; (5) The patient has the symptoms of over-worried and the following three other symptoms: insomnia or much dream, palpitations, loss of appetite, easy fatigue, dizziness, easy sweating, sighing frequently.
Exclusion criteria
Exclusion criteria: (1) The presence of severe personality disorder, especially antisocial, borderline or performational personality disorder, which the investigators judged would affect the patients' compliance with the study protocol; (2) During screening, the results of biochemical, hematology, electrocardiogram or urine test were not within the normal range of laboratory values and were judged by the investigator to be clinically significant (except abnormal indicators that were reasonable in the study population, such as abnormal blood sugar and lipid indicators); (3) Patients with serious heart, liver, brain, lung, kidney and other serious diseases in the past or at present, who are not considered suitable for inclusion by the researchers; (4) Known history of allergy or comorbidities to the test drug or ingredient (history of allergic reactions, rashes, urticaria and other allergic reactions caused by the drug); (5) Patients who cannot undergo MRI examination; (6) Other conditions considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional connectivity strength, FC;amplitude of low frequency fluctuation, ALFF;NAA/Cr; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;36-item Short-Form,SF-36; | — |
Countries
China
Contacts
Public ContactSu Lyu
Department of Radiology, West China Hospital, Sichuan University
Outcome results
None listed