A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
NCT ID: NCT03093025
Last Updated: 2020-07-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
51 participants
INTERVENTIONAL
2017-07-03
2018-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TS-121 10mg
TS-121 10 mg
Orally taken once daily
TS-121 50mg
TS-121 50 mg
Orally taken once daily
Placebo
Placebo
Orally taken once daily
Interventions
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TS-121 10 mg
Orally taken once daily
TS-121 50 mg
Orally taken once daily
Placebo
Orally taken once daily
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Taisho Pharmaceutical R&D Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shoji Yasuda
Role: STUDY_CHAIR
Taisho Pharmaceutical R&D Inc.
Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
PAREXEL Early Phase Clinical Unit
Glendale, California, United States
Synergy East
Lemon Grove, California, United States
NRC Research Institute
Orange, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Compass Research
Orlando, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Chicago Research Center
Chicago, Illinois, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Midwest Research Group - St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
Global Medical Institutes
Princeton, New Jersey, United States
SPRI Clinical Trials
Brooklyn, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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TS121-US201
Identifier Type: -
Identifier Source: org_study_id
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