DepressionPhase 2UPLIFTNCT05686408

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

A Phase 2 study testing TNX-601 ER in people with Depression and Depressive Disorder, run by Tonix Pharmaceuticals, Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression, Depressive Disorder, Depressive Symptoms
What is being tested?: TNX-601 ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: 27 sitesUnited States
Study dates: 2 Mar 2023to 29 Sep 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female or male aged 18 to 65 years (inclusive).
Have a primary DSM-5 diagnosis of current MDD.
The duration of the current MDE must be at least 12 weeks.
Without psychotic or catatonic features.

Who cannot join

Psychiatric History:
Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa; lifetime opioid or lifetime sedative-hypnotic use disorders, as confirmed by the MINI 7.0.2.
Diagnosis of borderline personality disorder
Patients with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD. (If MDD is the primary diagnosis, patients with comorbid GAD, SAD, and panic disorder are allowed for randomization).
Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Cenexel ACMR - Atlanta
Atlanta, Georgia, 30331
Donald J. Garcia, Jr.
Austin, Texas, 78737
Cenexel CIT - Bellflower
Bellflower, California, 90706
Cenexel HRI - Berlin
Berlin, New Jersey, 08009
Northwest Clinical Trials
Boise, Idaho, 83704
Chicago Research Center
Chicago, Illinois, 60634
CT Clinical Research Associates
Cromwell, Connecticut, 06416
Futuresearch Trials of Dallas
Dallas, Texas, 75231
Cenexel Research - Decatur
Decatur, Georgia, 30030
Mountain View Clinical Research
Denver, Colorado, 80209
Core Clinical Research
Everett, Washington, 98201
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Behavioral Research Specialists
Glendale, California, 91206
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
West Broward Outpatient Clinic
Lauderhill, Florida, 33319
Synergy Research
Lemon Grove, California, 91945
Preferred Research Partners
Little Rock, Arkansas, 72211
Clinical Neuroscience Solutions - Memphis
Memphis, Tennessee, 38119
Segal Trials - North Miami
Miami Lakes, Florida, 33016
Excell Research
Oceanside, California, 92056
NCR Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions - Orlando
Orlando, Florida, 32801
Summit Research Network
Portland, Oregon, 97210
Cenexel CIT - Riverside
Riverside, California, 92506
Artemis Institute for Clinical Research
San Diego, California, 92103
Cenexel CNR - Sherman Oaks
Sherman Oaks, California, 91403
Viking Clinical Research
Temecula, California, 92951

Other trials in United States

About this study

Official title: 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)

Conditions: Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe
Being tested: TNX-601 ER, Placebo
Medical subject headings: Depression, Depressive Disorder, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TNX-601 ERDrug
Also called Tianeptine
Patients will take 1 tablet orally once daily for 6 weeks.
PlaceboDrug
Patients will take 1 tablet orally once daily for 6 weeks.

Study groups in NCT05686408
Study group	Role	What they receive
TNX-601 ER, 39.4 mg	Experimental	1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks. Receives: Drug: TNX-601 ER
Placebo	Placebo comparator	Placebo tablet taken orally once daily for 6 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Clinical Global Impression of Severity (CGI-S)
Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 7. Lower scores indicate less severe illness.
Measured: Day 1 and Week 6
Sheehan Disability Scale (SDS)
Change from Baseline (Visit 2) in the Sheehan Disability Scale (SDS) total score at Week 6. Scores range from 0 to 30. Lower scores indicate less impairment to activities.
Measured: Day 1 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202329 Sep 2023

First posted17 Jan 2023
Study start2 Mar 2023
Primary completion29 Sep 2023
Study completion29 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05686408
Sponsor's protocol ID: TNX-TI-M201
Acronym: UPLIFT
Status last verified: Jan 2025
First submitted: 6 Jan 2023
Last updated: 17 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05686408
Acronym / sponsor ID: UPLIFT / TNX-TI-M201
Conditions: Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Rho, Inc.
Study start: 2 Mar 2023 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 17 Jan 2023 (actual)
Results: Posted 17 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TNX-601 ER, 39.4 mg	Experimental	Drug: TNX-601 ER1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet taken orally once daily for 6 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female or male aged 18 to 65 years (inclusive).
Have a primary DSM-5 diagnosis of current MDD.

Key exclusion criteria (5 listed)

Psychiatric History:
Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TNX-601 ERAlso: TianeptinePatients will take 1 tablet orally once daily for 6 weeks.	Drug	TNX-601 ER, 39.4 mg
PlaceboPatients will take 1 tablet orally once daily for 6 weeks.	Drug	Placebo

Primary outcome

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

2 secondary outcomes

Clinical Global Impression of Severity (CGI-S)
Time frame: Day 1 and Week 6
Sheehan Disability Scale (SDS)
Time frame: Day 1 and Week 6

Results and safety

Results posted to the registry on 17 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	68	58
TNX-601 ER, 39.4 mg	64	53

Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: Day 1 and Week 6. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 68	TNX-601 ER, 39.4 mg n = 64
Value	-12.8 (1.32)	-12.7 (1.30)

Population analysed: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 68 (1.5%)	3 of 68 (4.4%)	0 of 68
TNX-601 ER, 39.4 mg	2 of 64 (3.1%)	7 of 64 (10.9%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory Sullivan, MD study director

Tonix Pharmaceuticals

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNX-601 ER in people with Depression and Depressive Disorder, run by Tonix Pharmaceuticals, Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Day 1 and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.