Comparison of Anyu Peibo With Placebo in Treatment of MDD，Ⅱb

Major Depressive Disorder Clinical Trial

Official title:

Safety and Efficacy Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅱb Stratified Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183505
• Other study ID #: AYPB-MDD-?b-1701
• Secondary ID: 2017ZX09304-020
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2017
• Est. completion date: November 29, 2018

Study information

• Verified date: September 2017
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression. And to provide some scientific evidence for protocol designing in following phase Ⅲ clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: November 29, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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; ? 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Anyu Peibo
Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
• Placebo
Placebo Capsule, twice per day, oral after breakfast and supper

Locations

Country	Name	City	State
China	Beijing Anding Hospital,Capital Medical University	Beijing	Beijing
China	Beijing HuiLongGuan Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Jiangxi Mental Hospital	Nanchang	Jiangxi
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Brain Hospital of Jilin Province	Siping	Jilin
China	Wuhan Mental Health Center	Wuhan	Hubei
China	XI'AN Mental Health Center	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Su Zhou YiHua Biotechnology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Examination		6 weeks
Other	AE	Adverse Events	6 weeks
Other	Laboratory Examination	Blood RT, Urinalysis, Hepatic function, Renal function, FBG, Lipid, CK, Thyroid Function Test and Serum-HCG(fertile women only)	6 weeks
Other	the Change of ECG from baseline		6 weeks
Primary	The change of total score from baseline in MADRS scale		6 weeks
Secondary	Clinical Response Rate according to MADRS		6 weeks
Secondary	Clinical Remission Rate according to MADRS		6 weeks
Secondary	Clinical Response Rate according to HAMD-17		6 weeks
Secondary	Clinical Remission Rate according to HAMD-17		6 weeks
Secondary	the Change of CGI (CGI-S, CGI-I) from baseline		6 weeks
Secondary	the Change of total score from baseline in HAMA	Hamilton Anxiety Rating Scale	6 weeks