Depression
Conditions
Interventions
Low-dose GABA group:Low-dose GABA (150mg/d)
High-dose GABA group:High-dose GABA (300mg/d)
Control group:Placebo
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: 18-65 years old male or female 2: Meets the DSM-5 criteria for depression 3: The Hamilton Depression Scale (HAMD-17) score was defined as HAMD-17=17, and the total scores of items 4 (difficulty falling asleep), 5 (not deep sleep) and 6 (waking up early) were =2 4: Subjects reported subjective cognitive impairment (e.g., difficulty concentrating, thinking slowly, difficulty in learning new things or remembering things) and Digit Symbol test (DSST) < 70 5: Subjects had not received treatment in the previous 14 days and were scheduled to receive escitalopram oxalate tablets as their basic antidepressant medication 6: The subjects had an education level of junior high school or above 7: Subjects were required to comply with the study requirements and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1: Previous or current history of schizophrenia spectrum or other psychotic disorders, bipolar or related disorders, neurodevelopmental disorders, substance-related and addictive disorders, attention deficithyperactivity disorder, organic mental disorder or mental disorder due to general illness etc. 2: The patient was diagnosed with treatment-resistant depression 3: The symptoms of depressive episode lasted for more than 6 months 4: Subjects had undergone any previous or current brain surgery 5: The subjects received psychophysical therapy such as Modified Electric Convulsive Therapy (MECT) or Transcranial Magnetic Stimulation (TMS) within 6 months 6: The subjects were at serious risk of suicide, HAMD-17 item 3 (suicide risk) =3 points 7: Patients with previous allergies to foodborne gamma-aminobutyric acid or similar products 8: Accompanied by serious or unstable physical diseases, including any cardiovascular, oncologic, renal, respiratory, endocrine, digestive, hematological or nervous system diseases; At the same time, the liver and kidney function indexes and thyroid function indexes of the subjects were required to be within the normal range 9: Use of any antibiotic medication, probiotic products, or laxatives within 1 month prior to study entry 10: Those who were pregnant or breastfeeding at screening or baseline, or who had a positive pregnancy test, or men or women of reproductive potential at the time of the study who were unable to use effective contraception; Or planned to become pregnant within 3 months of the start of the study 11: Patients who had participated in other drug clinical trials and received investigational drugs within 3 months before the first dose 12: Subjects who were deemed unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DSST; | — |
Secondary
| Measure | Time frame |
|---|---|
| HVLT-R;Stroop ;TMT-A;TMT-B;HAMD-17;HAMA;PDQ-D;QIDS-SR16;SDS;PSQI; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed