Major Depressive DisorderPhase 3NCT00042575
Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
A Phase 3 study testing Duloxetine in people with Major Depressive Disorder, run by Eli Lilly and Company at 9 sites in United States.
Trial summary
The Purposes of this Study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Duloxetine
- How many people
- 120 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2002to Aug 2002
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You must be at least 18 years old.
- You must be diagnosed with major depressive disorder
- You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.
Who cannot join
- You are a woman and are pregnant or breastfeeding.
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have a history of alcohol or drug dependence or abuse within the past 6 months.
- You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
- You have a serious medical illness.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Albuquerque, New Mexico
Study site
Bellevue, Washington
Study site
Belmont, Massachusetts
Study site
Gaithersburg, Maryland
Study site
Lafayette, Indiana
Study site
Omaha, Nebraska
Study site
Salt Lake City, Utah
Study site
Staten Island, New York
Study site
Trumbull, Connecticut
About this study
Official title: Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
The Purposes of this Study are to determine:
The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
Duloxetine might not have any good effects for you.
- Conditions
- Major Depressive Disorder
- Being tested
- Duloxetine
- Keywords
- Sad, blue, lack of energy, depressed, hopelessness, guilt
- Medical subject headings
- Depressive Disorder, Major, Fatigue, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2002 (estimated)
- Study startJun 2002
- Study completionAug 2002
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 Major 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042575
- Sponsor's protocol ID
- 6475
- Other IDs
- F1J-US-HMBY
- Status last verified
- Jul 2006
- First submitted
- 31 Jul 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Publications
Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.
PubMed 16845641
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
- Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
- ClinicalTrials.gov ID
- NCT00042575
- Acronym / sponsor ID
- 6475
- Conditions
- Major Depressive Disorder
- Keywords
- Sad, blue, lack of energy, depressed, hopelessness, guilt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Aug 2002
- First posted
- 5 Aug 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 Purposes of this Study are to determine:
The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
Duloxetine might not have any good effects for you.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You must be at least 18 years old.
- You must be diagnosed with major depressive disorder
- You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.
Key exclusion criteria (5 listed)
- You are a woman and are pregnant or breastfeeding.
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have a history of alcohol or drug dependence or abuse within the past 6 months.
- You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
- You have a serious medical illness.
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 | 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 16845641Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.
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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.
9 sites 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 in people with Major Depressive Disorder, run by Eli Lilly and Company at 9 sites 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 3 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 9 sites 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 NCT00042575, 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.