MedTrace Logo

A Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

NCT04598867 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-22

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo- and active-controlled study to assess the efficacy and safety of CD-008-0045 in patients with generalized anxiety disorder (GAD). Each patient will participate in the study for the period of approximately 37 weeks: Screening and Run-in period: 1 week; Study Treatment period: 32 weeks; Follow-up period: 4 weeks.

Conditions

  • Anxiety Disorder Generalized

Interventions

DRUG

CD-008-0045

CD-008-0045 20 mg capsules

DRUG

Placebo

Placebo capsules

DRUG

Afobazol

Afobazol 10 mg tabletes

Sponsors & Collaborators

  • ChemRar Research and Development Institute, LLC

    lead INDUSTRY

Principal Investigators

  • Margarita A Morozova, MD,PhD,Prof · "Research Center for Mental Health" Scientific Institution

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2023-05-31
Completion
2023-06-30

More Related Trials

Entities

Drugs

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 NCT04598867 on ClinicalTrials.gov