Placebo-Controlled Study of ONO-2333Ms in Patients With R... | NCT00514865

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

NCT00514865

Sponsor

Ono Pharma USA Inc

Status

Completed

Last Update Posted

Nov 28, 2023Actual

Enrollment

278Actual

Phase

Phase 2

Conditions

Major Depressive Disorder

Interventions

ONO-2333Ms Experimental 2
Placebo
ONO-2333Ms Experimental 1

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2007Actual

Primary Completion Date

Apr 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 7, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Nov 30, 2013

Certification/Extension First Submitted that Passed QC Review

Nov 30, 2013

Certification/Extension First Posted Date

Dec 25, 2013Estimated

Last Update Submitted Date

Nov 26, 2023

Last Update Posted Date

Nov 28, 2023Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ONO-2333Ms Experimental 2	Drug	5-10 mg QD(once a day) for 8 weeks	Experimental 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to treatment endpoint in the MADRS total score		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with recurrent major depressive disorder

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katsutoshi Hatakeyama, M.S.	Ono Pharma USA Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ono Pharma Investigtional Site		Atlanta	Georgia	30329	United States

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided