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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03093025
• Other study ID #: TS121-US201
• Status: Terminated
• Phase: Phase 2
• Start date: July 3, 2017
• Est. completion date: December 4, 2018

Study information

• Verified date: July 2020
• Source: Taisho Pharmaceutical R&D Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: December 4, 2018
• Est. primary completion date: November 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Hassman Research Institute	Berlin	New Jersey
United States	Boston Clinical Trials	Boston	Massachusetts
United States	SPRI Clinical Trials	Brooklyn	New York
United States	Chicago Research Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	PAREXEL Early Phase Clinical Unit	Glendale	California
United States	Alexian Brothers Behavioral Health Hospital	Hoffman Estates	Illinois
United States	Synergy East	Lemon Grove	California
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Compass Research	Orlando	Florida
United States	Global Medical Institutes	Princeton	New Jersey
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Midwest Research Group - St. Charles Psychiatric Associates	Saint Charles	Missouri
United States	St. Louis Clinical Trials	Saint Louis	Missouri
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical R&D Inc.

Country where clinical trial is conducted

United States, 

References & 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 V(1B) receptor antagonist, as adjunctive treatment for patients with major depressive disorder: A randomized, double-blind, placebo-controlled study. J Psychiatr Res. 2020 May 31;128:43-51. doi: 10.1016/j.jpsychires.2020.05.017. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hamilton Anxiety Scale (HAM-A)	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
Secondary	Symptoms of Depression Questionnaire (SDQ)	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
Secondary	Clinical Global Impression-Severity (CGI-S)	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
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)	Percentage of MADRS responders (= 50% reduction in total score) at Week 6	6 weeks
Secondary	Clinical Global Impression-Improvement (CGI-I)	Percentage of CGI-I improvers ("Very much improved" or "Much improved") at Week 6	6 weeks

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