A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
Public ClinicalTrials.gov record NCT04969510. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 2 Double-blind, Placebo-Controlled, Dose-Ranging Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Adjunctive and Monotherapy Treatment of Participants With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.
Study identification
- NCT ID
- NCT04969510
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 110 participants
Conditions and interventions
Conditions
Interventions
- 10 mg PRAX-114 Drug
- 20 mg PRAX-114 Drug
- 40 mg PRAX-114 Drug
- 60 mg PRAX-114 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 24, 2021 (Actual)
- Primary completion
- Jul 15, 2022 (Actual)
- Completion
- Aug 2, 2022 (Actual)
- Last update posted
- Aug 19, 2022
2021 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Praxis Research Site | Lafayette | California | 94549 | — |
| Praxis Research Site | Lemon Grove | California | 91945 | — |
| Praxis Research Site | Oceanside | California | 92056 | — |
| Praxis Research Site | Redlands | California | 92374 | — |
| Praxis Research Site | Jacksonville | Florida | 32256 | — |
| Praxis Research Site | Orange City | Florida | 32763 | — |
| Praxis Research Site | Orlando | Florida | 32801 | — |
| Praxis Research Site | Atlanta | Georgia | 30331 | — |
| Praxis Research Site | Decatur | Georgia | 30030 | — |
| Praxis Research Site | Gaithersburg | Maryland | 20877 | — |
| Praxis Research Site | Boston | Massachusetts | 02131 | — |
| Praxis Research Site | Worcester | Massachusetts | 01655 | — |
| Praxis Research Site | O'Fallon | Missouri | 63368 | — |
| Praxis Research Site | Las Vegas | Nevada | 89102 | — |
| Praxis Research Site | Cedarhurst | New York | 11516 | — |
| Praxis Research Site | Rochester | New York | 14618 | — |
| Praxis Research Site | Dayton | Ohio | 45417 | — |
| Praxis Research Site | Allentown | Pennsylvania | 18104 | — |
| Praxis Research Site | Media | Pennsylvania | 19063 | — |
| Praxis Research Site | Memphis | Tennessee | 38119 | — |
| Praxis Research Site | Austin | Texas | 78737 | — |
| Praxis Research Site | Charlottesville | Virginia | 22903 | — |
| Praxis Research Site | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04969510, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2022 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04969510 live on ClinicalTrials.gov.