A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder

NCT02395978 | Completed Phase 2 Results

• 1 other identifier: Phase II BLI-1005-002
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and efficacy in patients with major depressive disorder.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II.

  The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 extremely despondent\]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).

  From Baseline to Week 6

Secondary Outcomes (9)

• Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II.

  From Baseline to Week 2, 4, 7

• Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.

  From Baseline to Week 2, 4, 6 and 7

• Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.

  From Baseline to Week 2, 4, 6 and 7

• Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II

  From Baseline to Week 2, 4, 6 and 7

• Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II.

  From Baseline to Week 2, 4, 6 and 7

Study Arms (5)

Part I: 1 PDC-1421 Capsule

EXPERIMENTAL

1 PDC-1421 Capsule TID, p.o. after meal for 28 days

Drug: PDC-1421 Capsule

Part I: 2 PDC-1421 Capsule

EXPERIMENTAL

2 PDC-1421 Capsule TID, p.o. after meal for 28 days

Drug: PDC-1421 Capsule

Part II: 2 PDC-1421 Capsule

EXPERIMENTAL

2 PDC-1421 Capsule TID, p.o. after meal for 42 days

Drug: PDC-1421 Capsule

Part II: 1 PDC-1421 Capsule plus 1 placebo

EXPERIMENTAL

1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days

Drug: PDC-1421 Capsule; Drug: placebo

Part II: 2 placebo

PLACEBO COMPARATOR

2 placebo TID, p.o. after meal for 42 days

Drug: placebo

Interventions

PDC-1421 Capsule DRUG

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

Also known as: BLI-1005

Part I: 1 PDC-1421 Capsule; Part I: 2 PDC-1421 Capsule; Part II: 1 PDC-1421 Capsule plus 1 placebo; Part II: 2 PDC-1421 Capsule

placebo DRUG

Placebo contained corn starch.

Part II: 1 PDC-1421 Capsule plus 1 placebo; Part II: 2 placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients aged 20-65 years
• Subjects must be able to understand and willing to sign informed consent
• Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
• Met criteria for MDD without psychotic features as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision® (DSM-IV-TR) and confirmed by use of the Mini International Neuropsychiatric Interview (MINI).
• item HAM-D (Hamilton Rating Scale for Depression) total score ≧20 and CGI (Clinical Global Impression) total score ≧4

You may not qualify if:

• Have a current or previous major psychiatric disorders which be defined to be per the DSM-IV-TR, including obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episode, schizophrenia, major Axis II disorders which might compromise the study, and major depression with psychotic symptoms, mental retardation.
• Use of any treatment for MDD in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
• Use of psychoactive drugs within the last 2 weeks before visit 1 other than that subjects had insomnia who need the treatment as determined by the Investigator.
• Subjects who were non-responsive to two or more courses of antidepressant medications given an adequate dosage for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.
• Have a history of any seizure disorder.
• Any clinically significant abnormal vital sign, ECG, laboratory values as determined by the investigator which might interfere with the study.
• Any organic disorder caused u medical related depression which cannot be under well-controlled such as clinically significant in neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders
• Have a high suicidal risk as measured by MINI.
• Have a history of substance abuse within the past 6 months or a positive urine drug screen for any substance of abuse at visit 1.
• Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.

Sponsors & Collaborators

• BioLite, Inc.: lead

Study Sites (5)

Stanford Depression Research Clinic

San Francisco, California, 94305, United States

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital, Neihu Main Facility

Taipei, Taiwan

Location

Wan Fang Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Hsien-Ming Wu
• Organization: BioLite, Inc.

sonnywu@bioliteinc.com

+886-6579631

Study Officials

• Richard King, Ph.D.

  American BriVision Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: Part I is a open label, dose escalation with two dosage levels study. Part II is a randomized (1:1:1), double-blind, placebo-controlled, parallel groups with three treatment arms.

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: March 24, 2015
• Study Start: April 10, 2015
• Primary Completion: March 12, 2019
• Study Completion: March 18, 2019
• Last Updated: July 22, 2021
• Results First Posted: September 29, 2020

Record last verified: 2019-11

Locations

US (1); TW (4)