Depression
Conditions
Interventions
Experimental group:Simvastatin 20mg per day combined with SSRI-type drugs, used in combination for 2 weeks
Control group:Simvastatin mimetic at a dose of 20 mg per day combined with SSRI drugs, for a duration of 2 weeks
Sponsors
Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient is capable of giving consent (he/she can understand the nature and expected effects/side effects of the proposed medical intervention) and voluntarily signs a written informed consent form; 2. The patient's age is between 18 and 65 years old (>=18 and =90cm, women >=85cm; 3) Height and weight standards: 20% above the standard weight. For men, the standard weight = (height -80cm) *0.7; for women, the standard weight = (height -70cm) *0.6. 4) Deltoid skin folds: male > 2.5cm, female > 3.0cm; 5) Laboratory tests show abnormal lipid metabolism (one of the following conditions is acceptable) : TC >=5.2 mmol/L; LDL-C>=3.4 mmol/L; TG>=1.7 mmol/L; Non-hdl-c >=4.1 mmol/L; Lp (a) >=300 mg/L; 4. Patients with depressive disorders (meeting the ICD-10 diagnostic criteria); 5. At screening and baseline, the total score of the standard score of the Self-rating depression scale (SDS) of the patients (>=50 and <=70).
Exclusion criteria
Exclusion criteria: 1. The patient meets any other diagnostic criteria for mental disorders below ICD-10: including having generalized anxiety disorder within 6 months prior to the screening of this trial, having a past or current schizophrenia spectrum or other psychotic disorders, bipolar or related disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, anorexia nervosa or bulimia nervosa and personality disorders, etc. 2. The patient has acute suicidal tendencies; 3. Those who have undergone psychosurgery or physical therapy for mental disorders (such as transcranial magnetic stimulation, electroconvulsive therapy (ECT), etc.) within the three months prior to screening; 4. Those who have received systematic psychological treatment or other non-pharmaceutical treatments for mental disorders (such as acupuncture or light therapy, etc.) within 6 weeks prior to screening; 5. People with cardiovascular diseases (such as a history of myocardial infarction or stroke, symptomatic peripheral artery disease, single-gene familial hypercholesterolemia), liver diseases, kidney diseases, blood diseases, endocrine diseases (such as untreated hypothyroidism), malignant tumors and other physical diseases; 6. The patient has a known history of gastrointestinal diseases or surgical history that may interfere with drug absorption or excretion; 7. The patient has known allergies or contraindications to SSris or statins; 8. The patient is currently using statins. 9. The patient is pregnant or a fertile patient is unwilling to use an acceptable contraceptive method; 10. The patient has participated in or plans to participate in other interventional trials within 6 months before and after participating in this trial. 11. For research reasons, patients are reluctant to agree to the retention, processing and use of medical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the patient's self-rating depression scale score compared to the baseline;The change in BMI index compared to the baseline;Changes in lipid profile (particularly low-density lipoprotein cholesterol (LDL-C)) compared to the baseline level; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in the Self-Rating Anxiety Scale (SAS) of the patients compared to the baseline; | — |
Countries
China
Contacts
Public ContactLi Tao
Affiliated Mental Health Center & Hangzhou Seventh People's Hospital, Zhejiang University
Outcome results
None listed