Comparison of Anyu Peibo With Placebo in Treatment of MDD

NCT02380066 | Completed Phase 2

• 2 other identifiers: AYPB-MDD-Ⅱa-14012012ZX09303-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• The change of total score from baseline in MADRS scale

  6 weeks

Secondary Outcomes (8)

• clinical response rate according to MADRS

  6 weeks

• clinical remission rate according to MADRS

  6 weeks

• CGI(CGI-S,CGI-I)

  6 weeks

• The change of total score from baseline in HAMD scale

  6 weeks

• decreasing rate from baseline in HAMD scale

  6 weeks

Other Outcomes (5)

• vital sign

  6 weeks

• AE(adverse events)

  6 weeks

• laboratory examination

  6 weeks

Study Arms (5)

Anyu Peibo 0.4g per day

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.2g twice per day

Drug: Anyu Peibo

Anyu Peibo 0.8g per day

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.4g twice per day

Drug: Anyu Peibo

Anyu Peibo 1.2g per day

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.6g twice per day

Drug: Anyu Peibo

Anyu Peibo 1.6g per day

EXPERIMENTAL

Anyu Peibo Capsule, oral, 0.8g twice per day

Drug: Anyu Peibo

Placebo

PLACEBO COMPARATOR

Placebo,oral, twice per day

Drug: Anyu Peibo

Interventions

Anyu Peibo DRUG

Placebo

Also known as: Placebo

Anyu Peibo 0.4g per day; Anyu Peibo 0.8g per day; Anyu Peibo 1.2g per day; Anyu Peibo 1.6g per day; 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-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
• The total score of HAMD-17 is ≥18 and ≤24 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.

You may not qualify if:

• The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide attempt.
• The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
• When the HAMD17 score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
• Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease.
• Had a history of seizure disorder,except infantile febrile convulsion.
• The subject has accepted psychosurgery or electroconvulsive therapy within 3months.
• With psychotic symptoms.
• The subject has a history of mania episode, including manic, mixed or rapid cycle attack.
• The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition.
• The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond.
• Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function or thyroid gland function index above toplimit, routine blood, fasting blood glucose value above or below 1.1 times of the upper limit of normal or in 1.1 times with the clinical significance of abnormality).
• The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit.
• Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs, or serious allergic physique.
• Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures.
• The subject could not take medication according to the doctor's advice. i.e. the compliance of the subject is poor.

Sponsors & Collaborators

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

Study Sites (6)

Anhui province hospital of TCM

Hefei, Anhui, 230031, China

Location

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangzhou Huiai Hospital

Guangzhou, Guangdong, 510370, China

Location

Jiangsu province hospital of TCM

Nanjing, Jiangsu, 210029, China

Location

Wuxi Mental Health Center

Wuxi, Jiangsu, 214151, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Huafang LI, MD PhD

  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: February 13, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 2, 2020

Record last verified: 2015-03

Locations

CN (6)