At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 132 enrolled
Drug / intervention
TNX-601 ER +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating TNX-601 ER and Placebo for Depression and 5 related conditions. Completed, enrolled 132 participants across 27 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe
CountriesUnited States
CollaboratorsRho, Inc.
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedJan 2023
Enrollment StartMar 2023
Primary CompletionSep 2023
TodayJul 2026
First PostedJan 17, 2023
Enrollment StartMar 2, 2023
Primary CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.5 years ago
Interventions
TNX-601 ERdrug
Patients will take 1 tablet orally once daily for 6 weeks.
Placebodrug
Patients will take 1 tablet orally once daily for 6 weeks.