DepressionPhase 3NCT00062673
Study of Duloxetine in Elderly Patients With Major Depressive Disorder
A Phase 3 study testing Duloxetine in people with Depression and Cognition, run by Eli Lilly and Company at 1 site in United States.
Trial summary
A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Cognition
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jul 2004
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- You must be able to visit the doctor's office for clinic visits, tests, and procedures.
- You must have been diagnosed with major depression, and have had at least one other episode in the past.
Who cannot join
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have taken a drug within the last 30 days that has not been approved for use by governmental authorities.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Middleton, Wisconsin
About this study
Official title: Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder
A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder
Read the detailed description
Duloxetine 60 mg QD and placebo variable-duration, placebo lead-in period 9 weeks in the acute treatment phase
- Conditions
- Depression, Cognition
- Being tested
- Duloxetine, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Verbal Learning & Recall Test (VLRT)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Symbol Digit Substitution Test (SDST)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from 2-Digit Cancellation Test (2DCT)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Letter-Number Sequencing Test (LNST)
Secondary outcomes (7)
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Geriatric Depression Scale (GDS)
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the 17-item Hamilton Depression Rating Scale (HAMD17) total score
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by response and remission rates
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Clinical Global Impressions of Severity Scale (CGI Severity) and the HAMD17 subscale scores
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on the painful physical symptoms of depression, as measured by the Visual Analog Scale for pain (VAS)
To compare the safety of duloxetine 60 mg QD and placebo using information on vital signs, electrocardiograms (ECGs), treatment-emergent adverse events, discontinuation-emergent adverse events, discontinuation rates and laboratory analyses
To assess the impact of treatment with duloxetine 60 mg QD and placebo on quality of life as measured by the Short-Form (SF-36) Health Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startMar 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- 311 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00062673
- Sponsor's protocol ID
- 6091
- Other IDs
- F1J-MC-HMBV
- Status last verified
- May 2007
- First submitted
- 10 Jun 2003
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
PubMed 25080392Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.
PubMed 23138680Raskin J, Wiltse CG, Dinkel JJ, Walker DJ, Desaiah D, Katona C. Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder. J Clin Psychopharmacol. 2008 Feb;28(1):32-8. doi: 10.1097/jcp.0b013e318160738e.
PubMed 18204338Wise TN, Wiltse CG, Iosifescu DV, Sheridan M, Xu JY, Raskin J. The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. Int J Clin Pract. 2007 Aug;61(8):1283-93. doi: 10.1111/j.1742-1241.2007.01476.x. Epub 2007 Jun 22.
PubMed 17590215Raskin J, Xu JY, Kajdasz DK. Time to response for duloxetine 60 mg once daily versus placebo in elderly patients with major depressive disorder. Int Psychogeriatr. 2008 Apr;20(2):309-27. doi: 10.1017/S1041610207005649. Epub 2007 Jun 22.
PubMed 17588276Raskin J, Wiltse CG, Siegal A, Sheikh J, Xu J, Dinkel JJ, Rotz BT, Mohs RC. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial. Am J Psychiatry. 2007 Jun;164(6):900-9. doi: 10.1176/ajp.2007.164.6.900.
PubMed 17541049
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Versus Placebo in the Treatment of Elderly Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00062673
- Acronym / sponsor ID
- 6091
- Conditions
- Depression, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 12 Jun 2003 (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.
A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder
Detailed description
Duloxetine 60 mg QD and placebo variable-duration, placebo lead-in period 9 weeks in the acute treatment phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- You must be able to visit the doctor's office for clinic visits, tests, and procedures.
- You must have been diagnosed with major depression, and have had at least one other episode in the past.
Key exclusion criteria (2 listed)
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have taken a drug within the last 30 days that has not been approved for use by governmental authorities.
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 | – |
| Placebo | Drug | – |
Primary outcome
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Verbal Learning & Recall Test (VLRT)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Symbol Digit Substitution Test (SDST)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from 2-Digit Cancellation Test (2DCT)
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Letter-Number Sequencing Test (LNST)
7 secondary outcomes
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Geriatric Depression Scale (GDS)
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the 17-item Hamilton Depression Rating Scale (HAMD17) total score
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by response and remission rates
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on depression as measured by the Clinical Global Impressions of Severity Scale (CGI Severity) and the HAMD17 subscale scores
To compare the efficacy of treatment with duloxetine 60 mg QD and placebo on the painful physical symptoms of depression, as measured by the Visual Analog Scale for pain (VAS)
To compare the safety of duloxetine 60 mg QD and placebo using information on vital signs, electrocardiograms (ECGs), treatment-emergent adverse events, discontinuation-emergent adverse events, discontinuation rates and laboratory analyses
To assess the impact of treatment with duloxetine 60 mg QD and placebo on quality of life as measured by the Short-Form (SF-36) Health Survey
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 21 May 2007.
- Derived from this study: PubMed 25080392Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
- Derived from this study: PubMed 23138680Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.
- Derived from this study: PubMed 18204338Raskin J, Wiltse CG, Dinkel JJ, Walker DJ, Desaiah D, Katona C. Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder. J Clin Psychopharmacol. 2008 Feb;28(1):32-8. doi: 10.1097/jcp.0b013e318160738e.
- Derived from this study: PubMed 17590215Wise TN, Wiltse CG, Iosifescu DV, Sheridan M, Xu JY, Raskin J. The safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity. Int J Clin Pract. 2007 Aug;61(8):1283-93. doi: 10.1111/j.1742-1241.2007.01476.x. Epub 2007 Jun 22.
- Derived from this study: PubMed 17588276Raskin J, Xu JY, Kajdasz DK. Time to response for duloxetine 60 mg once daily versus placebo in elderly patients with major depressive disorder. Int Psychogeriatr. 2008 Apr;20(2):309-27. doi: 10.1017/S1041610207005649. Epub 2007 Jun 22.
- Derived from this study: PubMed 17541049Raskin J, Wiltse CG, Siegal A, Sheikh J, Xu J, Dinkel JJ, Rotz BT, Mohs RC. Efficacy of duloxetine on cognition, depression, and pain in elderly patients with major depressive disorder: an 8-week, double-blind, placebo-controlled trial. Am J Psychiatry. 2007 Jun;164(6):900-9. doi: 10.1176/ajp.2007.164.6.900.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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
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 in people with Depression and Cognition, 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 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 21 May 2007. 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.
What does the primary outcome measure?
To compare the efficacy of duloxetine 60 mg QD & placebo on cognition during acute treatment phase in elderly patients using a composite cognitive score derived from the Verbal Learning & Recall Test (VLRT). The study lists 4 primary outcomes in all. 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 NCT00062673, which also lists 6 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 21 May 2007.