Major Depressive DisorderPhase 2NCT00514865
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
A Phase 2 study testing ONO-2333Ms Experimental 2 and ONO-2333Ms Experimental 1 in people with Major Depressive Disorder, run by Ono Pharma USA Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ONO-2333Ms Experimental 2 and ONO-2333Ms Experimental 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2007to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with recurrent major depressive disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ono Pharma Investigtional Site
Atlanta, Georgia, 30329
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Being tested
- ONO-2333Ms Experimental 2, Placebo, ONO-2333Ms Experimental 1
- Keywords
- ONO-2333Ms, Major Depressive Disorder
- 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.
ONO-2333Ms Experimental 2Drug
5-10 mg QD(once a day) for 8 weeks
PlaceboDrug
0 mg QD(once a day) for 8 weeks
ONO-2333Ms Experimental 1Drug
1-2 mg QD(once a day) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | 1-2 mg of ONO-2333 Receives: Drug: ONO-2333Ms Experimental 1 |
| Experimental 2 | Experimental | 5-10 mg of ONO-2333 Receives: Drug: ONO-2333Ms Experimental 2 |
| Placebo | Placebo comparator | placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to treatment endpoint in the MADRS total score
Measured: 8 weeks
Secondary outcomes (1)
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study start13 Jun 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsutoshi Hatakeyama, M.S., Study director, Ono Pharma USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514865
- Sponsor's protocol ID
- ONO-2333POU007
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2007
- Last updated
- 28 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00514865
- Acronym / sponsor ID
- ONO-2333POU007
- Conditions
- Major Depressive Disorder
- Keywords
- ONO-2333Ms, Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2007 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
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 and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: ONO-2333Ms Experimental 11-2 mg of ONO-2333 |
| Experimental 2 | Experimental | Drug: ONO-2333Ms Experimental 25-10 mg of ONO-2333 |
| Placebo | Placebo comparator | Drug: Placeboplacebo comparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed with recurrent major depressive disorder
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ONO-2333Ms Experimental 25-10 mg QD(once a day) for 8 weeks | Drug | Experimental 2 |
| Placebo0 mg QD(once a day) for 8 weeks | Drug | Placebo |
| ONO-2333Ms Experimental 11-2 mg QD(once a day) for 8 weeks | Drug | Experimental 1 |
Primary outcome
Change from baseline to treatment endpoint in the MADRS total score
Time frame: 8 weeks
1 secondary outcome
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Katsutoshi Hatakeyama, M.S. study director
Ono Pharma USA Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2333Ms Experimental 2 and ONO-2333Ms Experimental 1 in people with Major Depressive Disorder, run by Ono Pharma USA Inc at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to treatment endpoint in the MADRS total score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.