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

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05686408
Collaborator
Rho, Inc. (Industry)
300
Enrollment
2
Arms
12.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: TNX-601 ER
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: TNX-601 ER, 39.4 mg

1x TNX-601 ER, 39.4 mg, pill taken orally once daily for 6 weeks.

Drug: TNX-601 ER
Patients will take 1 pill orally once daily for 6 weeks.
Other Names:
  • Tianeptine

    		•
    Placebo Comparator: Placebo

    Placebo pill taken orally once daily for 6 weeks.

    Drug: Placebo
    Patients will take 1 pill orally once daily for 6 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Montgomery Asberg Depression Rating Scale (MADRS) [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.

    Secondary Outcome Measures

    1. Clinical Global Impression of Severity (CGI-S) [Day 1 and 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 7. Lower scores indicate less severe illness.

    2. Sheehan Disability Scale (SDS) [Day 1 and Week 6]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female or male aged 18 to 65 years (inclusive).

    • Have a primary DSM-5 diagnosis of current MDD.

    1. The duration of the current MDE must be at least 12 weeks.

    2. Without psychotic or catatonic features.

    Exclusion Criteria:
    • Psychiatric History:

    1. 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.

    2. Diagnosis of borderline personality disorder

    3. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.
    • Rho, Inc.

    Investigators

    • Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05686408
    Other Study ID Numbers:
    • TNX-TI-M201
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease
    Depression
    Depressive Disorder
    Depressive Disorder, Major
    Tianeptine

    Study Results

    No Results Posted as of Jan 17, 2023