Clinical trial NCT03183505 (phase 2, status: completed)
Conditions: major depressive disorder
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40
Drugs: anyu peibo, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria
             of DSM-5, single episode or recurrent episode.

          -  The total score of MADRS is ≥24 in both screening visit and baseline visit.

          -  The total score of HAMD-17 is ≥18 and the first item (depressed mood) is ≥2 in both
             screening visit and baseline visit.

          -  CGI-S is ≥4 in both screening visit and baseline visit.

          -  The subject understands and consents to takes part in this clinical trials. The
             subjects should sign informed consent form.

        Exclusion Criteria:

          -  The subject has a suicide attempt within recent 1 year, or has a currently significant
             risk of suicide, or has a score ≥3 on item 3(suicide assessment) of the HAMD.

          -  The subject has a current psychiatric diagnosis other than depression.

          -  When the HAMD-17 score of baseline visit compares with the screening visit, the
             decreasing rate is ≥25%.

          -  Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs.

          -  Any unstable cardiovascular, hepatic, renal, blood, endocrine, or other medical
             disease.

          -  Any neurological disease (such as Parkinson's Disease, cerebrovascular accident and
             epilepsy) or cerebral injury (traumatic or disease related).

          -  Had a history or a high risk related disease or medication of seizure disorder,except
             infantile febrile convulsion.

          -  Had a history of hyperthyroidism or hypothyroidism within recent 1 year and still
             taking medication.

          -  With psychotic symptoms.

          -  The subject has a history of mania episode, including manic, mixed, bipolar depression
             or rapid cycle attack.

          -  The subject has a current diagnosis of depression due to a somatic disease.

          -  The subject could not take medication or has a disease affecting drug absorption, such
             as active bowel disease, partial or total intestinal obstruction, or chronic diarrhea.

          -  Clinically significant electrocardiographic(ECG) abnormalities in screening visit.
             Such as QTc ≥450 ms in male or ≥470 ms in female; Sinus bradycardia and HR ≤ 50 bpm; Ⅲ
             atrioventricular block; atrial fibrillation, etc.

          -  Clinically significant abnormal laboratory values(eg. Routine blood value above or
             below 1.2 times of the normal range; urine WBC, RBC or protein ≥++; ALT or AST value
             above 1.5 times of clinical top-limit; BUN value above 1.2 times of top-limit; Cr
             value above normal top-limit; thyroid gland function index above or below 1.2 times of
             the normal range, Fasting plasma glucose value above 1.2 times of normal top-limit;
             blood fat value above 1.5 times of normal top-limit).

          -  The subject who used at least two different antidepressants with recommended dose and
             adequate duration (maximum dosage by at least 4 weeks according to label) treatment
             still had no respond.

          -  The subject uses antidepressant drug normally before 2 weeks of screening, and stops
             using psychotropic drug before randomization less than 7 half-life period (monoamine
             oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month)

          -  The subject received light therapy within 2 weeks.

          -  The subject received ECT, trans-cranial magnetic stimulation, or other physics therapy
             within 3 months.

          -  The subject received systematic psychotherapy (interpersonal relationship,
             psychoanalytic therapy, or cognitive behavioral therapy) within 3 months or plan to
             use systematic psychotherapy during the study period.

          -  The subject has a history of substance abuse (including alcohol, drug or other
             psychoactive substance) within 1 year before screening.

          -  Women who were pregnant, breast-feeding, or serum-HCG(+) on screening; or planning to
             become pregnant within 3 months after kick-off of clinical trial.

          -  The subject has participated in a drug clinical trial within 1 month before screening.

          -  The investigator thinks the subject is unsuitable to enroll in this clinical trial.