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

NCT ID: NCT05686408

Last Updated: 2025-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2023-09-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Depression Depressive Disorder Depressive Symptoms Depressive Disorder, Major Depressive Episode Depression Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TNX-601 ER, 39.4 mg

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

Group Type EXPERIMENTAL

TNX-601 ER

Intervention Type DRUG

Patients will take 1 tablet orally once daily for 6 weeks.

Placebo

Placebo tablet taken orally once daily for 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will take 1 tablet orally once daily for 6 weeks.

Interventions

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TNX-601 ER

Patients will take 1 tablet orally once daily for 6 weeks.

Intervention Type DRUG

Placebo

Patients will take 1 tablet orally once daily for 6 weeks.

Intervention Type DRUG

Other Intervention Names

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Tianeptine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rho, Inc.

INDUSTRY

Sponsor Role collaborator

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Sullivan, MD

Role: STUDY_DIRECTOR

Tonix Pharmaceuticals

Locations

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Preferred Research Partners

Little Rock, Arkansas, United States

Site Status

Cenexel CIT - Bellflower

Bellflower, California, United States

Site Status

Behavioral Research Specialists

Glendale, California, United States

Site Status

Synergy Research

Lemon Grove, California, United States

Site Status

Excell Research

Oceanside, California, United States

Site Status

NCR Research Institute

Orange, California, United States

Site Status

Cenexel CIT - Riverside

Riverside, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Cenexel CNR - Sherman Oaks

Sherman Oaks, California, United States

Site Status

Viking Clinical Research

Temecula, California, United States

Site Status

Mountain View Clinical Research

Denver, Colorado, United States

Site Status

CT Clinical Research Associates

Cromwell, Connecticut, United States

Site Status

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Site Status

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, United States

Site Status

West Broward Outpatient Clinic

Lauderhill, Florida, United States

Site Status

Segal Trials - North Miami

Miami Lakes, Florida, United States

Site Status

Clinical Neuroscience Solutions - Orlando

Orlando, Florida, United States

Site Status

Cenexel ACMR - Atlanta

Atlanta, Georgia, United States

Site Status

Cenexel Research - Decatur

Decatur, Georgia, United States

Site Status

Northwest Clinical Trials

Boise, Idaho, United States

Site Status

Chicago Research Center

Chicago, Illinois, United States

Site Status

Cenexel HRI - Berlin

Berlin, New Jersey, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, United States

Site Status

Donald J. Garcia, Jr.

Austin, Texas, United States

Site Status

Futuresearch Trials of Dallas

Dallas, Texas, United States

Site Status

Core Clinical Research

Everett, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TNX-TI-M201

Identifier Type: -

Identifier Source: org_study_id

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