Depressive Disorder, MajorPhase 3NCT00191919
A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain
A Phase 3 study testing Duloxetine Hydrochloride in people with Depressive Disorder, Major, run by Eli Lilly and Company at 38 sites in 6 countries.
Trial summary
To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Duloxetine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 38 sitesin 6 countries
- Study dates
- May 2005to May 2006
- 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
- Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history
- Painful physical symptoms as measured by the Brief Pain Inventory-Short Form
Who cannot join
- Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia)
- Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
Germany14 sites
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Berlin
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Bielefeld, 33647
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Bochum
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Chemnitz, 09111
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Erbach im Odenwald, 64711
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Freiburg im Breisgau, 79102
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Giessen, 35392
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Göttingen, 37075
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Hattingen, 45525
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Karlsruhe, 76199
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Künzing, 94550
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Leipzig, 04105
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Mannheim, 68159
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München, 80336
Belgium8 sites
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Antwerpert, 2018
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Asse, 1730
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Assebroek, 8310
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Diest, 3290
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Genk, 3600
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Leuven, 3000
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Ostend, 8400
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Yvoir, 5530
France7 sites
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Arcachon, 33120
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Cherbourg, 50100
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Élancourt, 78990
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Nantes-Orvault, 44700
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Paris, 75012
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Rennes, 35000
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Toulouse, 31200
Finland4 sites
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Espoo, FI-02650
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Helsinki, FI-00530
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Tampere, FI-33200
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Turku, FI-20100
Slovakia4 sites
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Bratislava
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Košice
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Michalovce
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Rimavaska Sobota
Czechia1 site
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Prague
About this study
Official title: A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain
To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment
- Conditions
- Depressive Disorder, Major
- Being tested
- Duloxetine Hydrochloride, Placebo
- 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.
Duloxetine HydrochlorideDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
Secondary outcomes (2)
Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF.
Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 310 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191919
- Sponsor's protocol ID
- 8605
- Other IDs
- F1J-BI-HMDH
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Publications
Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Time course of improvement of different symptom clusters in patients with major depression and pain treated with duloxetine or placebo. Curr Med Res Opin. 2012 Jan;28(1):41-8. doi: 10.1185/03007995.2011.645561. Epub 2011 Dec 22.
PubMed 22126422Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
PubMed 19333404Brecht S, Courtecuisse C, Debieuvre C, Croenlein J, Desaiah D, Raskin J, Petit C, Demyttenaere K. Efficacy and safety of duloxetine 60 mg once daily in the treatment of pain in patients with major depressive disorder and at least moderate pain of unknown etiology: a randomized controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1707-16. doi: 10.4088/jcp.v68n1110.
PubMed 18052564
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain
- ClinicalTrials.gov ID
- NCT00191919
- Acronym / sponsor ID
- 8605
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- May 2005
- Study completion
- May 2006
- First posted
- 19 Sep 2005 (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.
To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history
- Painful physical symptoms as measured by the Brief Pain Inventory-Short Form
Key exclusion criteria (2 listed)
- Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia)
- Any diagnosis of bipolar disorder, 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 | – |
| Placebo | Drug | – |
Primary outcome
Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
2 secondary outcomes
Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF.
Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.
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 26 Jan 2007.
- Derived from this study: PubMed 22126422Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Time course of improvement of different symptom clusters in patients with major depression and pain treated with duloxetine or placebo. Curr Med Res Opin. 2012 Jan;28(1):41-8. doi: 10.1185/03007995.2011.645561. Epub 2011 Dec 22.
- Derived from this study: PubMed 19333404Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
- Derived from this study: PubMed 18052564Brecht S, Courtecuisse C, Debieuvre C, Croenlein J, Desaiah D, Raskin J, Petit C, Demyttenaere K. Efficacy and safety of duloxetine 60 mg once daily in the treatment of pain in patients with major depressive disorder and at least moderate pain of unknown etiology: a randomized controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1707-16. doi: 10.4088/jcp.v68n1110.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
38 sites in 6 countries: 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, Major, run by Eli Lilly and Company at 38 sites in 6 countries.
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 2 inclusion and 2 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Belgium, France, Finland, Slovakia and 1 more country. 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.
What does the primary outcome measure?
Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00191919, which also lists 3 linked publications.
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 26 Jan 2007.