Clinical trial NCT03093025: A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Patients With Major Depressive Disorder With an Inadequate Response to Current Antidepressant Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Adjunctive Treatment
Lead sponsor: Taisho Pharmaceutical R&D Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).


Eligibility criteria: Inclusion Criteria:

1. Adult males and females between 18 and 65 years of age inclusive (at time of initial informed consent)
2. Patients with a current diagnosis of MDD by DSM-5, confirmed through a structured interview using MINI
3. Patients who receive the same antidepressant (SSRI, SNRI or bupropion monotherapy) for at least 6 weeks of continuous treatment with at least 4 weeks on a fixed dose
4. Patients who willing to remain on the same primary SSRI, SNRI or bupropion and fixed dose throughout the course of the study
5. Patients who meet the total score on the HAM-D as listed below

   1. HAM-D ≥ 18 at Screening
   2. HAM-D ≥ 18 at Baseline
6. Body Mass Index (BMI) ≥ 18 and ≤ 38 kg/m2

Exclusion Criteria:

1. Patients with inadequate response to ≥2 prior antidepressant treatments (not including current antidepressant) of at least 4 weeks duration each for the current episode
2. Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, post-partum (primary onset), or is secondary to a general medical disorder
3. Patients with a diagnosis of any of the following DSM-5 class disorders

   1. Schizophrenia spectrum and other psychotic disorders
   2. Bipolar and related disorders
   3. Anxiety disorders \[Co-morbid GAD and SAD will be allowed in the study if the primary diagnosis is MDD, and if in the opinion of the investigator, the comorbid anxiety is not likely to interfere with the subject's ability to participate in the trial or affect study outcome\]
   4. Obsessive-compulsive and related disorders
   5. Trauma- and Stressor-related disorders
4. Patients who received electroconvulsive therapy (ECT) within 12 months of Screening, received more than one course of ECT in their lifetime or plan to receive ECT during the study
5. Patients who received repetitive transcranial magnetic stimulation (rTMS) within 12 months of Screening or plan to receive rTMS during the study
6. Patients who plan to initiate or terminate cognitive or behavioral psychotherapy or alter the frequency of ongoing therapy during this study
7. Patients who have attempted suicide within the past 6 months
8. Patients with history or presence of intellectual disability, pervasive developmental disorder, cognitive disorder, neurodegenerative disorder, or brain injury
9. Patients with any history or complication of convulsive disorder
10. Patients who are undergoing treatment with psychotropic medications, benzodiazepines, metyrapone, lithium and/or corticosteroids
11. Patients who are taking moderate to strong CYP3A4 inhibitors/inducers

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: 6 weeks
measure: Symptoms of Depression Questionnaire (SDQ)
timeFrame: 6 weeks
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 6 weeks
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Glendale
country: United States
facility: PAREXEL Early Phase Clinical Unit
state: California
city: Lemon Grove
country: United States
facility: Synergy East
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Saint Charles
country: United States
facility: Midwest Research Group - St. Charles Psychiatric Associates
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
Study officials:
affiliation: Taisho Pharmaceutical R&D Inc.
name: Shoji Yasuda
role: STUDY_CHAIR
References:
citation: Kamiya M, Sabia HD, Marella J, Fava M, Nemeroff CB, Umeuchi H, Iijima M, Chaki S, Nishino I. Efficacy and safety of TS-121, a novel vasopressin V1B receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study. J Psychiatr Res. 2020 Sep;128:43-51. doi: 10.1016/j.jpsychires.2020.05.017. Epub 2020 May 31.