NCT05686408Phase 2Completed

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

Study sponsor: Tonix Pharmaceuticals, Inc.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-29Actual

Enrollment · participants132Actual

Source updated2025-02-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

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

Treatments or interventions studied

TNX-601 ERDrugAlso known as Tianeptine
PlaceboDrug

Primary outcomes · main study measures

measure: Montgomery Asberg Depression Rating Scale (MADRS); description: Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.; timeFrame: Day 1 and Week 6

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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