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Trial record 1 of 1 for:    NCT05686408
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Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (UPLIFT)

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ClinicalTrials.gov Identifier: NCT05686408
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : March 15, 2023
Sponsor:
Collaborator:
Rho, Inc.
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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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
Depression Depressive Disorder Depressive Symptoms Depressive Disorder, Major Depressive Episode Depression Severe Drug: TNX-601 ER Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Actual Study Start Date : March 2, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Global Impression of Severity (CGI-S) [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686408


Contacts
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Contact: Project Manager 212-980-9155 ashild.peters@tonixpharma.com

Locations
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United States, Florida
Clinical Neuroscience Solutions, Inc Recruiting
Orlando, Florida, United States, 32801
Contact: Ashild Peters    619-991-0553    ashild.peters@tonixpharma.com   
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Rho, Inc.
Investigators
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Study Director: Gregory Sullivan, MD Tonix Pharmaceuticals
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05686408    
Other Study ID Numbers: TNX-TI-M201
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Tianeptine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs