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

NCT03183505 | Completed Phase 2

• 2 other identifiers: AYPB-MDD-Ⅱb-17012017ZX09304-020
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The change of total score from baseline in MADRS scale

  6 weeks

Secondary Outcomes (6)

• Clinical Response Rate according to MADRS

  6 weeks

• Clinical Remission Rate according to MADRS

  6 weeks

• Clinical Response Rate according to HAMD-17

  6 weeks

• Clinical Remission Rate according to HAMD-17

  6 weeks

• the Change of CGI (CGI-S, CGI-I) from baseline

  6 weeks

Other Outcomes (4)

• Physical Examination

  6 weeks

• AE

  6 weeks

• Laboratory Examination

  6 weeks

Study Arms (2)

Anyu Peibo

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.8g twice per day

Drug: Anyu Peibo

Placebo

PLACEBO COMPARATOR

Placebo,oral, twice per day

Drug: Placebo

Interventions

Anyu Peibo DRUG

Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper

Also known as: Anyu Peibo Capsule

Anyu Peibo

Placebo DRUG

Placebo Capsule, twice per day, oral after breakfast and supper

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Su Zhou YiHua Biotechnology Co. LTD: collaborator

Study Sites (8)

Beijing Anding Hospital，Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Wuhan Mental Health Center

Wuhan, Hubei, 430022, China

Location

Jiangxi Mental Hospital

Nanchang, Jiangxi, 330029, China

Location

Brain Hospital of Jilin Province

Siping, Jilin, 136000, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

XI'AN Mental Health Center

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang LI, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 12, 2017
• Study Start: June 30, 2017
• Primary Completion: October 5, 2018
• Study Completion: November 29, 2018
• Last Updated: January 23, 2019

Record last verified: 2017-09

Locations

CN (8)