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A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

ConditionsMajor Depressive Episode (MDE)Major Depressive Disorder (MDD)Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTonix Pharmaceuticals, Inc.

About this trial

The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are:

Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL?

Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder.

Participants will:

Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary DSM-5 diagnosis of current MDD.

The duration of the current MDE must be between 6 weeks and 18 months.

Without psychotic or catatonic features.

Capable of reading and understanding English and able to provide written informed consent to participate.

Disqualifiers

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,

Diagnosis of borderline personality disorder that is known, suspected

Participants 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.

Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TNX-102 SL

    Drug

    Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

  • Placebo sublingual tablet

    Drug

    Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: TNX-102 SLExperimental treatment 1 intervention
Group B: Placebo sublingual tabletsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline (Visit 2) in the MADRS total score at 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.

Time frame
From Day 1 to Week 6

Secondary outcomes

1

Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6

Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 5. Lower scores indicate less severe illness.

Time frame
From Day 1 to Week 6
2

Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6

Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).

Time frame
From Day 1 to Week 6
3

Change from Baseline (Visit 2) in the MADRS total score at Week 4.

Change from Baseline (Visit 2) in the MADRS total score at Week 4. Scores range from 0 to 60. Lower scores indicate less depression.

Time frame
From Day 1 to Week 4
4

Change from Baseline (Visit 2) in the MADRS total score at Week 2.

Change from Baseline (Visit 2) in the MADRS total score at Week 2. Scores range from 0 to 60. Lower scores indicate less depression.

Time frame
From Day 1 to Week 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tonix Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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