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

NCT03093025 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: TS121-US201
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 22

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).

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Adjunctive Treatment

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  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 Outcomes (5)

• Hamilton Anxiety Scale (HAM-A)

  6 weeks

• Symptoms of Depression Questionnaire (SDQ)

  6 weeks

• Clinical Global Impression-Severity (CGI-S)

  6 weeks

• Montgomery-Asberg Depression Rating Scale (MADRS)

  6 weeks

• Clinical Global Impression-Improvement (CGI-I)

  6 weeks

Study Arms (3)

TS-121 10mg

EXPERIMENTAL

Drug: TS-121 10 mg

TS-121 50mg

EXPERIMENTAL

Drug: TS-121 50 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TS-121 10 mg DRUG

Orally taken once daily

TS-121 10mg

TS-121 50 mg DRUG

Orally taken once daily

TS-121 50mg

Placebo DRUG

Orally taken once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females between 18 and 65 years of age inclusive (at time of initial informed consent)
• Patients with a current diagnosis of MDD by DSM-5, confirmed through a structured interview using MINI
• 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
• Patients who willing to remain on the same primary SSRI, SNRI or bupropion and fixed dose throughout the course of the study
• Patients who meet the total score on the HAM-D as listed below
• HAM-D ≥ 18 at Screening
• HAM-D ≥ 18 at Baseline
• Body Mass Index (BMI) ≥ 18 and ≤ 38 kg/m2

You may not qualify if:

• Patients with inadequate response to ≥2 prior antidepressant treatments (not including current antidepressant) of at least 4 weeks duration each for the current episode
• Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, post-partum (primary onset), or is secondary to a general medical disorder
• Patients with a diagnosis of any of the following DSM-5 class disorders
• Schizophrenia spectrum and other psychotic disorders
• Bipolar and related disorders
• Anxiety disorders \[Co-morbid GAD and SAD will be allowed in the study if the primary diagnosis is MDD, and if in the opinion of the investigator, the comorbid anxiety is not likely to interfere with the subject's ability to participate in the trial or affect study outcome\]
• Obsessive-compulsive and related disorders
• Trauma- and Stressor-related disorders
• 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
• Patients who received repetitive transcranial magnetic stimulation (rTMS) within 12 months of Screening or plan to receive rTMS during the study
• Patients who plan to initiate or terminate cognitive or behavioral psychotherapy or alter the frequency of ongoing therapy during this study
• Patients who have attempted suicide within the past 6 months
• Patients with history or presence of intellectual disability, pervasive developmental disorder, cognitive disorder, neurodegenerative disorder, or brain injury
• Patients with any history or complication of convulsive disorder
• Patients who are undergoing treatment with psychotropic medications, benzodiazepines, metyrapone, lithium and/or corticosteroids

Sponsors & Collaborators

• Taisho Pharmaceutical R&D Inc.: lead

Study Sites (22)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

PAREXEL Early Phase Clinical Unit

Glendale, California, 91206, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Midwest Research Group - St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Global Medical Institutes

Princeton, New Jersey, 08540, United States

Location

SPRI Clinical Trials

Brooklyn, New York, 11235, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Related Publications (1)

• 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.

  PMID: 32521250 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Taisho Pharmaceutical R&D Inc. Study Director
• Organization: Taisho Pharmaceutical R&D Inc.

ClinicalTrials@taisho-rd.com

800-602-0203

Study Officials

• Shoji Yasuda

  Taisho Pharmaceutical R&D Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 28, 2017
• Study Start: July 3, 2017
• Primary Completion: November 8, 2018
• Study Completion: December 4, 2018
• Last Updated: July 14, 2020
• Results First Posted: December 9, 2019

Record last verified: 2020-07

Locations

US (22)