Trials / Completed
CompletedNCT05686408
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Tonix Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).
Conditions
- Depression
- Depressive Disorder
- Depressive Symptoms
- Depressive Disorder, Major
- Depressive Episode
- Depression Severe
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNX-601 ER | Patients will take 1 tablet orally once daily for 6 weeks. |
| DRUG | Placebo | Patients will take 1 tablet orally once daily for 6 weeks. |
Timeline
- Start date
- 2023-03-02
- Primary completion
- 2023-09-29
- Completion
- 2023-09-29
- First posted
- 2023-01-17
- Last updated
- 2025-02-17
- Results posted
- 2025-02-17
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05686408. Inclusion in this directory is not an endorsement.