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

July 1, 2020 updated by: Taisho Pharmaceutical R&D Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Orally taken once daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). The total score is the sum of 10 items and can take range from 0 to 60. A negative change from baseline indicates improvement.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Scale (HAM-A)
Time Frame: 6 weeks
The HAM-A is a clinician-rated scale to assess anxiety symptoms which consists from 14 items. The time frame for this scale is the past 7 days. Each item is scored on 5-point scale (0 [absence of symptoms] to 4 [severe]). The total score is the sum of 14 items and can take range from 0 to 56. A negative change from baseline indicates improvement.
6 weeks
Symptoms of Depression Questionnaire (SDQ)
Time Frame: 6 weeks
The SDQ is a self-rated scale to assess the severity of symptoms across several subtypes of depression which consists from 44 items. The time frame for this scale is the past 7 days. Each item is scored on 6-point scale (1 [better than normal] to 6 [severe]). The total score is the sum of 44 items and can take range from 44 to 264. A negative change from baseline indicates improvement.
6 weeks
Clinical Global Impression-Severity (CGI-S)
Time Frame: 6 weeks
The CGI-S is a clinician-rated scale to assess the severity of the disorder. The time frame for this scale is the past 7 days. The score ranges from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).
6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
Percentage of MADRS responders (≥ 50% reduction in total score) at Week 6
6 weeks
Clinical Global Impression-Improvement (CGI-I)
Time Frame: 6 weeks
Percentage of CGI-I improvers ("Very much improved" or "Much improved") at Week 6
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical R&D Inc.

Investigators

  • Study Chair: Shoji Yasuda, Taisho Pharmaceutical R&D Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2017

Primary Completion (ACTUAL)

November 8, 2018

Study Completion (ACTUAL)

December 4, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS121-US201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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