Depression Clinical Trial
— UPLIFTOfficial 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)
Verified date | March 2024 |
Source | Tonix Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 132 |
Est. completion date | September 29, 2023 |
Est. primary completion date | September 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cenexel ACMR - Atlanta | Atlanta | Georgia |
United States | Donald J. Garcia, Jr. | Austin | Texas |
United States | Cenexel CIT - Bellflower | Bellflower | California |
United States | Cenexel HRI - Berlin | Berlin | New Jersey |
United States | Northwest Clinical Trials | Boise | Idaho |
United States | Chicago Research Center | Chicago | Illinois |
United States | CT Clinical Research Associates | Cromwell | Connecticut |
United States | Futuresearch Trials of Dallas | Dallas | Texas |
United States | Cenexel IResearch - Decatur | Decatur | Georgia |
United States | Mountain View Clinical Research | Denver | Colorado |
United States | Core Clinical Research | Everett | Washington |
United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
United States | Behavioral Research Specialists | Glendale | California |
United States | Clinical Neuroscience Solutions - Jacksonville | Jacksonville | Florida |
United States | West Broward Outpatient Clinic | Lauderhill | Florida |
United States | Synergy Research | Lemon Grove | California |
United States | Preferred Research Partners | Little Rock | Arkansas |
United States | Clinical Neuroscience Solutions - Memphis | Memphis | Tennessee |
United States | Segal Trials - North Miami | Miami Lakes | Florida |
United States | Excell Research | Oceanside | California |
United States | NCR Research Institute | Orange | California |
United States | Clinical Neuroscience Solutions - Orlando | Orlando | Florida |
United States | Summit Research Network | Portland | Oregon |
United States | Cenexel CIT - Riverside | Riverside | California |
United States | Artemis Institute for Clinical Research | San Diego | California |
United States | Cenexel CNR - Sherman Oaks | Sherman Oaks | California |
United States | Viking Clinical Research | Temecula | California |
Lead Sponsor | Collaborator |
---|---|
Tonix Pharmaceuticals, Inc. | Rho, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 and Week 6 | |
Secondary | 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. | Day 1 and Week 6 | |
Secondary | 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. | Day 1 and Week 6 |
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