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A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03093025
Recruitment Status : Active, not recruiting
First Posted : March 28, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Taisho Pharmaceutical R&D Inc.

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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: TS-121 10 mg Drug: TS-121 50 mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 3, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TS-121 10mg Drug: TS-121 10 mg
Orally taken once daily

Experimental: TS-121 50mg Drug: TS-121 50 mg
Orally taken once daily

Placebo Comparator: Placebo Drug: Placebo
Orally taken once daily




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
    Change in MADRS total score from Baseline to End of Treatment estimated for 8 weeks


Secondary Outcome Measures :
  1. Hamilton Anxiety Scale (HAM-A) [ Time Frame: 8 weeks ]
    Change in HAM-A total score from Baseline to End of Treatment estimated for 8 weeks

  2. Symptoms of Depression Questionnaire (SDQ) [ Time Frame: 8 weeks ]
    Change in SDQ total score from Baseline to End of Treatment estimated for 8 weeks

  3. Clinical Global Impression-Severity (CGI-S) [ Time Frame: 8 weeks ]
    Change in CGI-S score from Baseline to End of Treatment estimated for 8 weeks

  4. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
    Percentage of MADRS responders (≥ 50% reduction in total score) estimated for 8 weeks

  5. Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks ]
    Percentage of CGI-I improvers ("Very much improved" or "Much improved") estimated for 8 weeks



Information from the National Library of Medicine

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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:

  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

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): NCT03093025


Locations
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
United States, California
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
PAREXEL Early Phase Clinical Unit
Glendale, California, United States, 91206
Synergy East
Lemon Grove, California, United States, 91945
NRC Research Institute
Orange, California, United States, 92868
United States, Colorado
MCB Clinical Research Centers
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Chicago Research Center
Chicago, Illinois, United States, 60634
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60169
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
United States, Missouri
Midwest Research Group - St. Charles Psychiatric Associates
Saint Charles, Missouri, United States, 63304
St. Louis Clinical Trials
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
Global Medical Institutes
Princeton, New Jersey, United States, 08540
United States, New York
SPRI Clinical Trials
Brooklyn, New York, United States, 11235
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
Sponsors and Collaborators
Taisho Pharmaceutical R&D Inc.
Investigators
Study Chair: Shoji Yasuda Taisho Pharmaceutical R&D Inc.

Responsible Party: Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier: NCT03093025     History of Changes
Other Study ID Numbers: TS121-US201
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taisho Pharmaceutical R&D Inc.:
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms