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

> **NCT05686408** · PHASE2 · COMPLETED · sponsor: **Tonix Pharmaceuticals, Inc.** · enrollment: 132 (actual)

## Conditions studied

- Depression
- Depressive Disorder
- Depressive Symptoms
- Depressive Disorder, Major
- Depressive Episode
- Depression Severe

## Interventions

- **DRUG:** TNX-601 ER
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05686408
- **Lead sponsor:** Tonix Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2023-03-02
- **Primary completion:** 2023-09-29
- **Final completion:** 2023-09-29
- **Target enrollment:** 132 (ACTUAL)
- **Last updated:** 2025-02-17

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05686408

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05686408, "Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT05686408. Licensed CC0.

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