Depression in Patients With Mild to Moderate Depression

Study Overview
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Brief Summary
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The main purpose of this clinical trial is to evaluate the clinical efficacy and safety of adjuvant intervention therapy software for depression in patients with mild to moderate depression

Detailed Description
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The main purpose of this clinical trial is to evaluate the clinical efficacy and safety of adjuvant intervention therapy software for depression in patients with mild to moderate depression under the premise of ensuring the safety of the subjects and ensuring the scientificity of the clinical trial.

Official Title
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A Prospective, Randomized, Multicenter, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of Adjuvant Intervention Software for Depression in Patients With Mild to Moderate Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Depression Auxiliary Intervention Treatment Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients voluntarily participate in the trial and sign the informed consent; Age 18-60 years old (including 18 years old and 60 years old), gender is not limited; The clinical diagnosis complies with the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5 (through the International Neuropsychiatry Brief Interview Questionnaire (Mini- International Neuropsychiatric Interview, M.I.N.I.) confirming the diagnosis) without psychotic symptoms; Patients with Montgomery Depression Rating Scale (MADRS) score greater than or equal to 12 and less than 30 at screening; Patients who have not received antidepressant systemic treatment within 2 weeks before screening, and who can maintain no need for antidepressant treatment during the trial period as assessed by the research doctor; or take serotonin reuptake stably for at least 6 weeks before screening Inhibitor (Selective Serotonin Reuptake Inhibitor, SSRI) class, or serotonin and norepinephrine reuptake dual inhibitor (Serotonin-Norepinephrine Reuptake Inhibitor, SNRI) class, or noradrenergic and specific serotonergic Antidepressants (Noradrenergic and Specific Serotonergic Antidepressants, NaSSA) antidepressants, and the medication compliance is 80%-120% and the drug dose adjustment is less than 20%, and the antidepressant treatment can be maintained during the trial period as assessed by the clinician patients on the original treatment regimen; Patients with primary school education or above, who can understand the content of the scale and can use smart phones proficiently. Exclusion Criteria: Patients whose clinical diagnosis meets the diagnostic criteria for other mental disorders except depression in DSM-5 (diagnosis confirmed by M.I.N.I.); Patients with refractory depression (those who have been treated with 2 or more antidepressants with different chemical structures in the past or currently, and who have been treated with a sufficient dose and a full course of treatment (at least 4 weeks according to the maximum dose in the instructions) are ineffective); Patients with a history of alcohol and drug dependence; Pregnant or breastfeeding female patients, or male or female patients with reproductive plans during clinical trials; Those with 10. Suicidal ideation score of MADRS score greater than or equal to 4 points, that is, those with severe suicidal ideation or suicide attempt; Patients received other antidepressant treatment methods within 3 months before enrollment, including traditional Chinese medicine, modified electroconvulsive therapy (MECT), transcranial magnetic stimulation, biofeedback therapy, phototherapy, acupuncture and other physical therapy and system psychology treat; Severe physical disease, severe liver, renal insufficiency and thyroid disease (Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST) exceeds the upper limit of normal twice at screening, or total Bilirubin (Total Bilirubin, TBIL) exceeds 1.5 times the upper limit of normal; Creatinine (CR) exceeds 1.2 times the upper limit of normal; Thyroid Stimulating Hormone (TSH) exceeds the upper limit of normal), or as judged by the investigator Patients with other diseases who are not suitable for inclusion in this trial; upon the judgment of the investigator, a re-examination of non-compliant laboratory tests is allowed, but the re-examination must be completed within the screening period; Patients who clearly express their unwillingness to participate in psychotherapy, or who think that psychotherapy is ineffective; Patients who have participated in or are participating in drug clinical trials within 3 months before screening, or patients who have participated in or are participating in other device clinical trials within 1 month before screening; Other conditions judged by the investigator to be unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Conventional Treatment + Depression Auxiliary Intervention Treatment Software.A software used to treat depression, used frequently once a day. | Device: Depression Auxiliary Intervention Treatment Software<br>* Depression Auxiliary Intervention Treatment Software<br>|
| Placebo Comparator: control group<br>Conventional treatment + auxiliary intervention treatment software for depression (placebo software) | Device: Depression Auxiliary Intervention Treatment Software<br>* Depression Auxiliary Intervention Treatment Software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale | Montgomery-Asberg Depression Rating Scale.The maximum value of the Montgomery-Asberg Depression Rating Scale is 60, and the minimum value of the Montgomery-Asberg Depression Rating Scale is 0.Higher scores mean a worse outcome. | 56 days |