Anxiety disorder
Conditions
Interventions
Control group:Placebo, with no active ingredients, identical in appearance, color, and smell to food-derived GABA, 150 mg per tablet, take 2 tablets orally after dinner daily, produced by Huaxi Biotec
Experiment group:Food-derived GABA, 150 mg per tablet, take 2 tablets orally after dinner daily, produced by Huaxi Biotech Co., Ltd.Escitalopram Oxalate, 10 mg per tablet, take 1 tablet orally after b
Sponsors
Beijing Anding Hospital, affiliated with Capital Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for anxiety disorders, without psychotic symptoms; 2.Hamilton Anxiety 14-Item Scale (HAMA-14) score >=14 at screening and baseline; 3.HAMA entry 1 (anxious mind) score >=2 at screening and baseline; 4.Patients scheduled to receive Escitalopram Oxalate Tablets 10 mg QD as basic anti-anxiety treatment; 5.Ages 18-65, open to all genders; 6.Participants must be able to understand and comply with study requirements and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Disease-related exclusion criteria (1) Currently meet the diagnoses of other mental disorders according to DSM-5, such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive and related disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, substance-related and addictive disorders, etc.; (2) Currently at severe risk of suicide, with a score of >=3 on the HAMD-17 suicide risk item; (3) Accompanied by severe or unstable somatic diseases, including any cardiovascular, tumor, renal, respiratory, endocrine, digestive, hematologic, or nervous system diseases; Treatment-related exclusion criteria; (4) Use of sedative-hypnotic drugs within 1 week prior to the first administration of the study drug; (5) Treatment with fluoxetine within 4 weeks before the first administration, or treatment with antidepressants other than fluoxetine within 2 weeks before the first administration, including but not limited to tricyclic antidepressants, 5-HT agents (such as SSRIs, SNRIs, vilazodone), monoamine oxidase inhibitors, etc.; (6) Use of any antipsychotic or psychoactive drugs within 2 weeks prior to the first administration; (7) Receiving systemic psychotherapies (such as interpersonal therapy, psychodynamic therapy, cognitive-behavioral therapy), music therapy, exercise therapy, acupuncture, etc., at screening and/or baseline, and need to continue such therapies during the study period; (8) Undergoing physical therapy related to depression within 3 months before the first administration, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc.; (9) Previous use of at least 2 antidepressants with different mechanisms of action at adequate doses and for adequate duration without efficacy; 2.Medical-related exclusion criteria; 1. A reduction of >=25% in the HAMA-14 score at baseline compared to screening; 2. Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) >=2 times the upper limit of normal, or total bilirubin and/or direct bilirubin >=1.5 times the upper limit of normal, or serum creatinine >=1.5 times the upper limit of normal, or thyroid-stimulating hormone (TSH) levels outside the normal range at screening; 3. Clinically significant electrocardiogram (ECG) abnormalities at screening or baseline, such as a QTc interval of >=450 milliseconds for males and >=470 milliseconds for females; 4. Subjects who are pregnant or breastfeeding, test positive for pregnancy at screening or baseline, or males or females of reproductive potential who are unable to use effective contraceptive measures during the study period; or plan to conceive (either as a recipient or donor of sperm/egg) within 3 months after the start of the study; 5. Participation in other clinical drug trials and receipt of trial medication within 3 months before the first administration;Subjects deemed unsuitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Side Effects;Somatic symptoms;Rapid Action and Efficacy Rate;Sleep;Depression symptoms;Anxiety symptoms;State-Trait Anxiety Inventory;Heart Rate Variability;Event-Related Potential (ERP); | — |
Countries
China
Contacts
Public ContactWang Han
Beijing Anding Hospital, affiliated with Capital Medical University.
Outcome results
None listed