NCT00514865

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

August 7, 2007

Last Update Submit

November 26, 2023

Conditions

Major Depressive Disorder

Keywords

ONO-2333MsMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to treatment endpoint in the MADRS total score

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (3)

Experimental 1

EXPERIMENTAL

1-2 mg of ONO-2333

Drug: ONO-2333Ms Experimental 1

Experimental 2

EXPERIMENTAL

5-10 mg of ONO-2333

Drug: ONO-2333Ms Experimental 2

Placebo

PLACEBO COMPARATOR

placebo comparator

Drug: Placebo

Interventions

ONO-2333Ms Experimental 2DRUG

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

Experimental 2
PlaceboDRUG

0 mg QD(once a day) for 8 weeks

Placebo
ONO-2333Ms Experimental 1DRUG

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

Experimental 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with recurrent major depressive disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ono Pharma Investigtional Site

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Katsutoshi Hatakeyama, M.S.

    Ono Pharma USA Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 10, 2007

Study Start

June 13, 2007

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

US(1)