Comparison of Anyu Peibo With Placebo in Treatment of MDD in China

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210973
• Other study ID #: AYPB-MDD-?-201901
• Secondary ID: 2018ZX09734-005
• Status: Recruiting
• Phase: Phase 3
• Start date: January 23, 2020
• Est. completion date: May 2021

Study information

• Verified date: December 2019
• Source: Shanghai Mental Health Center
• Contact: Huafang LI, MD. PhD.
• Phone: 86-21-34773107
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: May 2021
• Est. primary completion date: December 2020
• 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. [296.21; 296.22; 296.23; 296.31; 296.32; 296.33]

• The total score of MADRS is =26 in both screening visit and baseline visit.

• The first item of MADRS is =3 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 current psychiatric diagnosis other than depression.

• 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 10 (suicidal ideation) of MADRS.

• The subject has a current depressive episode due to somatic general disease or a neurological disease, such as hypothyroidism.

• When the MADRS total 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.

• The subject could not take medication or has a disease affecting drug absorption, distribution, metabolism and excretion.

• Clinically significant electrocardiographic(ECG) abnormalities in screening visit. Such as QTc =450 ms in male or =470 ms in female.

• Clinically significant abnormal laboratory values (eg. ALT or AST value above 2 times of clinical top-limit; Cr value above normal top-limit; thyroid gland function index (= 2 items in 5 items) above 1.2 times or below 0.8 times of the normal range, or investigator diagnosed with hypothyroidism or hyperthyroidism).

• 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 5 half-life period (monoamine oxidase inhibitor: at least 2 weeks; fluoxetine: at least 1 month).

• The subject received systematic light therapy, laser therapy and acupuncture or other Traditional Chinese Medicine, or systemic biofeedback therap within 2 weeks.

• The subject received modified ECT, trans-cranial magnetic stimulation (TMS), vagus nerve stimulation (VNS) or systematic psychotherapy within 3 months.

• 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.

• Education level below junior high school.

• 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	The Sixth People's Hospital of Hebei Province	Baoding	Hebei
China	Beijing Anding Hospital,Capital Medical University	Beijing	Beijing
China	Beijing HuiLongGuan Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Chongqing Mental Health Center	Chongqing	Chongqing
China	Guangzhou Brain Hospital	Guangzhou	Guangdong
China	Jiangxi Mental Hospital	Nanchang	Jiangxi
China	Ningbo Kangning Hospital	Ningbo	Zhejiang
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Brain Hospital of Jilin Province	Siping	Jilin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	XI'AN Mental Health Center	Xi'an	Shanxi
China	The Second Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Zhumadian mental Hospital	Zhumadian	Henan

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
Primary	The change of total score from baseline in Montgomery Asberg Depression Rating Scale (MADRS)	the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome	8 weeks
Secondary	Clinical Remission Rate according to total score of MADRS at the end of study	Remission=at the end of study, total score of MADRS =10, the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome	8 weeks
Secondary	Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study	Remission=at the end of study, total score of HAMD17 =7, the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome	8 weeks
Secondary	The change of total score of MADRS by time	the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome	8 weeks
Secondary	The change of total score from baseline in HAMD17	the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome	8 weeks
Secondary	The change of total score from baseline in Hamilton Anxiety Scale (HAMA)	the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome	8 weeks
Secondary	The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S)	the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome	8 weeks
Secondary	Clinical Global Impression-Severity of Illness (CGI-I) score	the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome	8 weeks
Secondary	The change of total score from baseline in Discriminative Scale Space Tracker (DSST)	the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome	8 weeks
Secondary	The change of total score from baseline in Trail Making Test (TMT) A&B	the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome	8 weeks
Secondary	The change of total score from baseline in Sheehan Disability Scale (SDS)	the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome	8 weeks
Secondary	Proportion of subjects who withdrew from clinical trial due to poor efficacy	Investigator will assess subject's efficacy according to his/her clinical status with rating scales, including MADRS, HAMD17, HAMA and CGI, which already listed in Outcome	8 weeks
Secondary	Proportion of subjects who combined medication to treat insomnia		8 weeks
Secondary	Incidence rate of AE	AE=Adverse Events	8 weeks
Secondary	Breath Rate	per minutes	8 weeks
Secondary	Pulse Rate	per minutes	8 weeks
Secondary	Heartbeat Rate	per minutes	8 weeks
Secondary	Diastolic blood pressure	Sitting position, mmHg	8 weeks
Secondary	Systolic blood pressure	Sitting position, mmHg	8 weeks
Secondary	Electrocardiogram(ECG)	the number of subjects with abnormal ECG report by 12-lead electrocardiogram	8 weeks
Secondary	Assessment of Arizona Sexual Experience Scale (ASES)	the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome	8 weeks
Secondary	Number of Participants with AE result in early withdrawal from clinical trials		8 weeks
Secondary	Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials		8 weeks
Secondary	Number of Emerging AE during drug withdrawal period		9 weeks

External Links

•   EMEA :Guideline on clinical investigation of medicinal products in the treatment of depression.
•   FDA.Major Depressive Disorder:Developing Drug for Treatment Guidance for Industry.