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COMPLETED Phase 2

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

NCT05686408 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 132 participants
Start Date 2023-03-02
Est. Completion 2023-09-29
Phase Phase 2

Sponsor

Tonix Pharmaceuticals

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05686408

The ClinicalTrials.gov registry entry for NCT05686408 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tonix Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05686408 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05686408?

The interventions under investigation include: Placebo (DRUG), TNX-601 ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05686408?

This trial is sponsored by Tonix Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial