Major Depressive DisorderPhase 2NCT03093025
A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder
A Phase 2 study testing TS-121 10 mg and TS-121 50 mg in people with Major Depressive Disorder, run by Taisho Pharmaceutical R&D Inc. at 22 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- TS-121 10 mg and TS-121 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 22 sitesUnited States
- Study dates
- 3 Jul 2017to 4 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 16Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Hassman Research Institute
Berlin, New Jersey, 08009
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials
Brooklyn, New York, 11235
Rush University Medical Center
Chicago, Illinois, 60612
Chicago Research Center
Chicago, Illinois, 60634
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Midwest Clinical Research Center
Dayton, Ohio, 45417
Collaborative Neuroscience Network
Garden Grove, California, 92845
PAREXEL Early Phase Clinical Unit
Glendale, California, 91206
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169
Synergy East
Lemon Grove, California, 91945
Woodland International Research Group
Little Rock, Arkansas, 72211
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
IPS Research Company
Oklahoma City, Oklahoma, 73103
NRC Research Institute
Orange, California, 92868
Compass Research
Orlando, Florida, 32806
Global Medical Institutes
Princeton, New Jersey, 08540
Woodland Research Northwest
Rogers, Arkansas, 72758
Midwest Research Group - St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304
St. Louis Clinical Trials
St Louis, Missouri, 63141
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
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
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
- Being tested
- TS-121 10 mg, TS-121 50 mg, Placebo
- Keywords
- Major Depressive Disorder, Adjunctive Treatment
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-121 10 mgDrug
Orally taken once daily
TS-121 50 mgDrug
Orally taken once daily
PlaceboDrug
Orally taken once daily
| Study group | Role | What they receive |
|---|---|---|
| TS-121 10mg | Experimental | Not described Receives: Drug: TS-121 10 mg |
| TS-121 50mg | Experimental | Not described Receives: Drug: TS-121 50 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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).
Measured: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Percentage of MADRS responders (≥ 50% reduction in total score) at Week 6
Measured: 6 weeks
Clinical Global Impression-Improvement (CGI-I)
Percentage of CGI-I improvers ("Very much improved" or "Much improved") at Week 6
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start3 Jul 2017
- Primary completion8 Nov 2018
- Study completion4 Dec 2018
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shoji Yasuda, Study chair, Taisho Pharmaceutical R&D Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093025
- Sponsor's protocol ID
- TS121-US201
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2017
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32521250
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03093025
- Acronym / sponsor ID
- TS121-US201
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Adjunctive Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TS-121 10mg | Experimental | Drug: TS-121 10 mg |
| TS-121 50mg | Experimental | Drug: TS-121 50 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-121 10 mgOrally taken once daily | Drug | TS-121 10mg |
| TS-121 50 mgOrally taken once daily | Drug | TS-121 50mg |
| PlaceboOrally taken once daily | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Hamilton Anxiety Scale (HAM-A)
Time frame: 6 weeks
Symptoms of Depression Questionnaire (SDQ)
Time frame: 6 weeks
Clinical Global Impression-Severity (CGI-S)
Time frame: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
Clinical Global Impression-Improvement (CGI-I)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32521250Kamiya 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoji Yasuda study chair
Taisho Pharmaceutical R&D Inc.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TS-121 10 mg and TS-121 50 mg in people with Major Depressive Disorder, run by Taisho Pharmaceutical R&D Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.