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NCT05686408 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
A Phase 2 study of Depression and Depressive Symptoms, sponsored by Tonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT05686408: Completed Phase 2 study of Depression and Depressive Symptoms, sponsored by Tonix Pharmaceuticals.
NCT05686408 is a Phase 2 study of Depression and Depressive Symptoms that has completed, run by Tonix Pharmaceuticals. The registered enrollment target is 132 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05686408, a Phase 2 study of Depression and Depressive Symptoms, has completed, sponsored by Tonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TNX-601 ER
Study Locations (20)
California
- Cenexel CIT - Bellflower - Bellflower
- Behavioral Research Specialists - Glendale
- Synergy Research - Lemon Grove
- Excell Research - Oceanside
- NCR Research Institute - Orange
- Cenexel CIT - Riverside - Riverside
- Artemis Institute for Clinical Research - San Diego
- Cenexel CNR - Sherman Oaks - Sherman Oaks
- Viking Clinical Research - Temecula
Florida
- Gulfcoast Clinical Research Center - Fort Myers
- Clinical Neuroscience Solutions - Jacksonville - Jacksonville
- West Broward Outpatient Clinic - Lauderhill
- Segal Trials - North Miami - Miami Lakes
- Clinical Neuroscience Solutions - Orlando - Orlando
Georgia
- Cenexel ACMR - Atlanta - Atlanta
- Cenexel Research - Decatur - Decatur
Arkansas
- Preferred Research Partners - Little Rock
Colorado
- Mountain View Clinical Research - Denver
Connecticut
- CT Clinical Research Associates - Cromwell
Idaho
- Northwest Clinical Trials - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-03-02 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
What the finished NCT05686408 record still lists
NCT05686408 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (83% lower).
The record links to 6 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05686408 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05686408 about?
NCT05686408 is a clinical study titled "Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)". 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).
What is the current status of trial NCT05686408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2023-03-02. Estimated completion is 2023-09-29.
What conditions does trial NCT05686408 study?
This clinical trial studies the following conditions: Depression, Depressive Symptoms, Depressive Disorder, Major, Depressive Disorder, Depression Severe.
What interventions are being tested in trial NCT05686408?
The interventions under investigation include: Placebo (DRUG), TNX-601 ER (DRUG).
Who is sponsoring clinical trial NCT05686408?
This trial is sponsored by Tonix Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05686408 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05686408's enrollment target sits among peer trials
132 282nd of 679 higher than 396 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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