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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT03093025

Run by

Taisho Pharmaceutical R&D Inc.

People needed

51

Starts

2017-07-03

Expected to finish

2018-12-04

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• Patients who are taking moderate to strong CYP3A4 inhibitors/inducers

Where it is running

• 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

Full record on ClinicalTrials.gov

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