328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram for Major Depressive Disorder (MDD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
For additional information regarding sites, contact 844-687-8522, Austin, TX
Major Depressive Disorder (MDD)+4 More
Centanafadine (328.8 mg) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD) who have reported inadequate response to at least 1 but no more than 3 treatments for depression in their current major depressive episode. The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram. The trial will consist of up to a 28-day screening period, a 6-week double-blind treatment period, and a 7-day safety follow-up period. The trial is planned to be conducted on an outpatient basis with 336 subjects in the United States.

Eligible Conditions

  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Major Depressive Disorder (MDD)

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, Day 4, Weeks 1, 2, 4, and 6

Week 1
Change from baseline to Week 6 in Symptoms of Major Depressive Disorder Scale (SMDDS) Total score
Week 1
Change from baseline to Week 6 in Clinical Global Impression - Severity (CGI-S) score
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Change from baseline to Week 6 in Patient Global Impression - Severity (PGI-S) score
Percentage of Subjects with MADRS Remission (where remission is defined as MADRS Total score ≤ 10)
Percentage of Subjects with MADRS Response (where response is defined as 50% reduction in MADRS Total score from baseline)
Screening and Week 6
Change from screening in Apathy Evaluation Scale - Self-rated (AES-S) score
Change from screening to Week 6 in 6-item Short-Form Health Survey Version 2 (SF-36v2)
Week 1
Mean Clinical Global Impression - Change (CGI-C) score
Mean Patient Global Impression - Change (PGI-C) score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Major Depressive Disorder (MDD)

Trial Design

4 Treatment Groups

Escitalopram + Placebo
1 of 4
328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo
1 of 4
328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram
1 of 4
Placebo + Placebo
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

336 Total Participants · 4 Treatment Groups

Primary Treatment: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram · Has Placebo Group · Phase 2

328.8 mg dose Total Daily Dose (TDD) Centanafadine + PlaceboExperimental Group · 2 Interventions: Centanafadine (328.8 mg), Placebo · Intervention Types: Drug, Drug
328.8 mg dose Total Daily Dose (TDD) Centanafadine + EscitalopramExperimental Group · 2 Interventions: Centanafadine (328.8 mg), Escitalopram · Intervention Types: Drug, Drug
Escitalopram + PlaceboActiveComparator Group · 2 Interventions: Placebo, Escitalopram · Intervention Types: Drug, Drug
Placebo + Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Escitalopram
2005
Completed Phase 4
~2540

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 4, weeks 1, 2, 4, and 6
Closest Location: For additional information regarding sites, contact 844-687-8522 · Austin, TX
Photo of Austin  1Photo of Austin  2Photo of Austin  3
2022First Recorded Clinical Trial
3 TrialsResearching Major Depressive Disorder (MDD)
11 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.