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

NCT02395978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-07-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

PDC-1421 Capsule

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

DRUG

placebo

Placebo contained corn starch.

Sponsors & Collaborators

  • BioLite, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard King, Ph.D. · American BriVision Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-10
Primary Completion
2019-03-12
Completion
2019-03-18

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395978 on ClinicalTrials.gov