Depressive DisorderPhase 3NCT00036309
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
A Phase 3 study testing Duloxetine Hydrochloride in people with Depressive Disorder, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Duloxetine Hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jul 2003
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent
- Meet criteria for major depressive disorder without psychotic features.
- Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
- Have had at least one other major depressive episode prior to the one being experienced at study entry.
- You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.
Who cannot join
- You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
- Any women who are pregnant or breast feeding.
- If you have any serious medical illnesses other than major depressive disorder.
- If you have previously participated in a clinical trial for duloxetine.
- Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
Durham, North Carolina
About this study
The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.
- Conditions
- Depressive Disorder
- Being tested
- Duloxetine Hydrochloride
- Keywords
- Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine HydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startMay 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036309
- Sponsor's protocol ID
- 4445
- Other IDs
- F1J-MC-HMBC
- Status last verified
- Jul 2006
- First submitted
- 8 May 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Publications
Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43. doi: 10.1186/1471-244X-7-43.
PubMed 17725843
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00036309
- Acronym / sponsor ID
- 4445
- Conditions
- Depressive Disorder
- Keywords
- Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Jul 2003
- First posted
- 9 May 2002 (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 determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed the informed consent
- Meet criteria for major depressive disorder without psychotic features.
- Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
- Have had at least one other major depressive episode prior to the one being experienced at study entry.
- You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.
Key exclusion criteria (5 listed)
- You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
- Any women who are pregnant or breast feeding.
- If you have any serious medical illnesses other than major depressive disorder.
- If you have previously participated in a clinical trial for duloxetine.
- Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.
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 |
|---|---|---|
| Duloxetine Hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jul 2006.
- Derived from this study: PubMed 17725843Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43. doi: 10.1186/1471-244X-7-43.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine Hydrochloride in people with Depressive Disorder, run by Eli Lilly and Company 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 5 inclusion and 5 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 19 Jul 2006. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00036309, 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 19 Jul 2006.