Major Depressive DisorderPhase 1NCT00414323
Evaluation of the Effects of Duloxetine on Norepinephrine
A Phase 1 study testing Duloxetine and Escitalopram in people with Major Depressive Disorder, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Duloxetine and Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to May 2007
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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.
Glendale, California, 91206
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.
San Antonio, Texas, 78229
About this study
Official title: Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects
The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.
- Conditions
- Major Depressive Disorder
- Being tested
- Duloxetine, Escitalopram, 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.
DuloxetineDrug
EscitalopramDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).
Secondary outcomes (4)
Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure.
Effect of duloxetine versus escitalopram on heart rate variability.
Ratio of duloxetine exposure in plasma to CSF at steady state.
Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startNov 2006
- Study completionMay 2007
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 35 participants (actual)
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
- NCT00414323
- Sponsor's protocol ID
- 9547
- Other IDs
- F1J-MC-HMEU
- Status last verified
- Jun 2007
- First submitted
- 15 Dec 2006
- Last updated
- 12 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00414323
- Acronym / sponsor ID
- 9547
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- May 2007 (actual)
- First posted
- 21 Dec 2006 (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 how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 | – |
| Escitalopram | Drug | – |
| Placebo | Drug | – |
Primary outcome
Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).
4 secondary outcomes
Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure.
Effect of duloxetine versus escitalopram on heart rate variability.
Ratio of duloxetine exposure in plasma to CSF at steady state.
Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma.
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 12 Jun 2007.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Duloxetine and Escitalopram in people with Major Depressive Disorder, run by Eli Lilly and Company at 2 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?
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 12 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).. 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 12 Jun 2007.