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CompletedNCT00514865Updated Nov 28, 2023

Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

A Phase 2 interventional study of ONO-2333Ms Experimental 2 and Placebo in Major Depressive Disorder, sponsored by Ono Pharma USA Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Ono Pharma USA Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • ONO-2333Ms
  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 278 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Ono Pharma USA Inc is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with recurrent major depressive disorder

Exclusion criteria

Exclusion Criteria:

  • Patients with treatment resistance for depression
  • History of alcohol abuse/dependence, substance abuse/dependence within 6 months
  • Has clinically significant unstable medical condition
  • Has significant risk of suicide
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
278 participants (actual)

Study arms

  • Experimental
    Experimental 1

    1-2 mg of ONO-2333

    Drug: ONO-2333Ms Experimental 1

  • Experimental
    Experimental 2

    5-10 mg of ONO-2333

    Drug: ONO-2333Ms Experimental 2

  • Placebo comparator
    Placebo

    placebo comparator

    Drug: Placebo

Interventions

  • DrugONO-2333Ms Experimental 2

    5-10 mg QD(once a day) for 8 weeks

  • DrugPlacebo

    0 mg QD(once a day) for 8 weeks

  • DrugONO-2333Ms Experimental 1

    1-2 mg QD(once a day) for 8 weeks

06

What researchers measure

Primary outcomes

  1. Change from baseline to treatment endpoint in the MADRS total score

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score

    Time frame: 8 weeks

07

Study locations

1 site
  • Ono Pharma Investigtional Site
    Atlanta, Georgia 30329, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00514865
Lead sponsor
Ono Pharma USA Inc
Responsible party
Sponsor
First posted
Aug 10, 2007
Start date
Jun 13, 2007
Primary completion
Apr 2008
Completion
Jun 2008
Last update
Nov 28, 2023

Study contacts

Katsutoshi Hatakeyama, M.S.
study director · Ono Pharma USA Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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