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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 8, 2018

Interventions

  • Drug: TS-121 10 mg
    • Orally taken once daily
  • Drug: TS-121 50 mg
    • Orally taken once daily
  • Drug: Placebo
    • Orally taken once daily

Arms, Groups and Cohorts

  • Experimental: TS-121 10mg
  • Experimental: TS-121 50mg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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).
  • Montgomery-Asberg Depression Rating Scale (MADRS)
    • Time Frame: 6 weeks
    • Percentage of MADRS responders (≥ 50% reduction in total score) at Week 6
  • Clinical Global Impression-Improvement (CGI-I)
    • Time Frame: 6 weeks
    • Percentage of CGI-I improvers (“Very much improved” or “Much improved”) at Week 6

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taisho Pharmaceutical R&D Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shoji Yasuda, Study Chair, Taisho Pharmaceutical R&D Inc.

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