Major Depressive DisorderPhase 1NCT01263223

A Study of LY2216684 in Major Depressive Disorder in Patients Taking Selective Serotonin Reuptake Inhibitors

A Phase 1 study testing LY2216684 in people with Major Depressive Disorder, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: LY2216684
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: Dec 2010to Mar 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Are patients that have been diagnosed with major depressive disorder (MDD) and are on a stable dose of an selective serotonin reuptake inhibitor (SSRI) for at least 4 weeks prior to enrollment, as determined by medical history and physical examination.
Male patients: Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
Female patients: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause for at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 milli-international-units/milliliter (mIU/mL).
Have a body mass index (BMI) of up to 32.0 kilogram/squaremeter (kg/m2).
Have normal blood pressure (BP) and pulse rate (systolic BP <140, diastolic BP <90; supine position and standing) as determined by the investigator.
Patients that have a diagnosis of hypertension but are well controlled on a stable dose (at least 4 weeks of diuretic, angiotensin converting enzyme [ACE]-inhibitor, or angiotensin 2 receptor inhibitor) are acceptable for inclusion in this study. Allowance of a specific anti-hypertensive is per the investigator's discretion.

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Have screening clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
Have venous access sufficient to allow blood sampling as per the protocol.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site.

Who cannot join

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to any compound related to LY2216684.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684.
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have a significant history of or presence of cardiovascular (including dysrhythmias), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any condition capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
Have unequal BP (> 20 millimeter of mercury [mm Hg]) in the left arm versus right arm (as measured with a BP cuff) or have absent or unequal radial pulses in either arm.

Show all 21Show fewer

Have a history of seizure disorders.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
Are women with a positive pregnancy test or women who are lactating.
Use of over-the-counter or prescription medication (other than stable doses of SSRI as noted above) with a narrow therapeutic index (including, but not limited to warfarin or clopidogrel) or those that are known to have an effect on heart rate (e.g., beta-blockers) within 14 days prior to dosing.
Use of any drugs or substances that are known to be a strong inducer or inhibitor of cytochrome P450 2D6 (CYP2D6) or cytochrome P450 3A4 (CYP3A4) within 30 days prior to check-in (study entry) and during the conduct of the study.
Have donated blood of more than 500 milliliter (mL) within 4 weeks prior to screening.
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to check-in (study entry)until the completion of the study (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any patients unwilling to adhere to study caffeine restrictions.
Patients must adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU.
Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment or are unwilling to avoid during the study.
Have a documented or suspected history of glaucoma.
Patients determined to be unsuitable by the investigator for any reason.

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.
Austin, Texas, 78731
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.
St Louis, Missouri, 63118

Other trials in United States

About this study

Official title: Effect of LY2216684 on Ambulatory Heart Rate and Blood Pressure in Patients With Major Depressive Disorder Who Are Being Treated With Selective Serotonin Reuptake Inhibitors

The purpose of this study is to determine the effect of LY2216684 on heart rate and blood pressure in research participants with MDD who are being treated with an SSRI (selective serotonin reuptake inhibitors). Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 24 days not including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18 mg LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four single daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.

Conditions: Major Depressive Disorder
Being tested: LY2216684, 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.

LY2216684Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT01263223
Study group	Role	What they receive
LY2216684, placebo, LY or placebo	Experimental	Period 1: 18 milligrams (mg) LY2216684 administered orally once daily on Days 1-4 Period 2: placebo administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4 Receives: Drug: LY2216684; Drug: Placebo
Placebo, LY2216684, placebo or LY	Experimental	Period 1: placebo administered orally once daily on Days 1-4 Period 2: 18 mg LY2216684 administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4 Receives: Drug: LY2216684; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1
Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 1
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4
Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4

Secondary outcomes (6)

Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Blood pressure (BP) was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 1. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 1
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4
Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Measured: Baseline through the 24-hour interval on Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Mar 2011

First posted20 Dec 2010 (estimated)
Study startDec 2010
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263223
Sponsor's protocol ID: 12607
Other IDs: H9P-EW-LNCP
Status last verified: Mar 2018
First submitted: 16 Dec 2010
Last updated: 23 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of LY2216684 on Ambulatory Heart Rate and Blood Pressure in Patients With Major Depressive Disorder Who Are Being Treated With Selective Serotonin Reuptake Inhibitors
ClinicalTrials.gov ID: NCT01263223
Acronym / sponsor ID: 12607
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Posted 23 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY2216684, placebo, LY or placebo	Experimental	Drug: LY2216684, Drug: PlaceboPeriod 1: 18 milligrams (mg) LY2216684 administered orally once daily on Days 1-4 Period 2: placebo administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4
Placebo, LY2216684, placebo or LY	Experimental	Drug: LY2216684, Drug: PlaceboPeriod 1: placebo administered orally once daily on Days 1-4 Period 2: 18 mg LY2216684 administered orally once daily on Days 1-4 Period 3: 36 mg LY2216684 or placebo administered orally daily on Days 1-4

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Are patients that have been diagnosed with major depressive disorder (MDD) and are on a stable dose of an selective serotonin reuptake inhibitor (SSRI) for at least 4 weeks prior to enrollment, as determined by medical history and physical examination.
Male patients: Agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
Female patients: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause for at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 milli-international-units/milliliter (mIU/mL).
Have a body mass index (BMI) of up to 32.0 kilogram/squaremeter (kg/m2).
Have normal blood pressure (BP) and pulse rate (systolic BP <140, diastolic BP <90; supine position and standing) as determined by the investigator.

Key exclusion criteria (21 listed)

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to any compound related to LY2216684.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684.
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have a significant history of or presence of cardiovascular (including dysrhythmias), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, or any condition capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.

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
LY2216684Administered orally	Drug	LY2216684, placebo, LY or placebo, Placebo, LY2216684, placebo or LY
PlaceboAdministered orally	Drug	LY2216684, placebo, LY or placebo, Placebo, LY2216684, placebo or LY

Primary outcome

Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1
Time frame: Baseline through the 24-hour interval on Day 1
Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4
Time frame: Baseline through the 24-hour interval on Day 4
Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.

6 secondary outcomes

Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Time frame: Baseline through the 24-hour interval on Day 1
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
Time frame: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4
Time frame: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
Time frame: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Time frame: Baseline through the 24-hour interval on Day 4
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Time frame: Baseline through the 24-hour interval on Day 4

Results and safety

Results posted to the registry on 23 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
18-mg LY2216684; Placebo; 36-mg LY2216684 or Placebo	12	12
Placebo; 18-mg LY2216684; Placebo or 36-mg LY2216684	12	12

Primary outcome: Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1

Time frame: Baseline through the 24-hour interval on Day 1. Least squares mean (90% Confidence Interval). Unit: beats per minute (bpm)

Measure	18-mg LY2216684 n = 23	Placebo n = 23
Mean Change	13.3 (9.9 to 16.7)	3.6 (0.3 to 6.9)
Maximum Change	57.5 (50.9 to 64.1)	33.1 (27.0 to 39.2)

18-mg LY2216684 vs Placebo: Mean Difference (Final Values): 9.7 (95% CI 7.4 to 12.0), p <0.0001, Mixed Models Analysis
18-mg LY2216684 vs Placebo: Mean Difference (Final Values): 24.4 (95% CI 17.9 to 30.9), p <0.0001, Mixed Models Analysis

Population analysed: All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.

Primary outcome: Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4

Time frame: Baseline through the 24-hour interval on Day 4. Least squares mean (90% Confidence Interval). Unit: beats per minute (bpm)

Measure	18-mg LY2216684 n = 22	Placebo n = 23
Mean Change	16.6 (13.2 to 20.1)	3.0 (-0.3 to 6.3)
Maximum Change	58.7 (52.1 to 65.4)	31.1 (25.0 to 37.2)

18-mg LY2216684 vs Placebo: Mean Difference (Final Values): 13.6 (95% CI 11.3 to 15.9), p <0.0001, Mixed Models Analysis
18-mg LY2216684 vs Placebo: Mean Difference (Final Values): 27.6 (95% CI 21.1 to 34.2), p <0.0001, Mixed Models Analysis

Population analysed: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 were made in Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Periods 1, 2, and 3 through 7-day follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18-mg LY2216684	0 of 24 (0%)	20 of 24 (83.3%)	Not reported
36-mg LY2216684	1 of 19 (5.3%)	12 of 19 (63.2%)	Not reported
Placebo	0 of 24 (0%)	14 of 24 (58.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 LY2216684 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?

The sponsor lists 10 inclusion and 21 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 23 Oct 2018. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1 (time frame: Baseline through the 24-hour interval on Day 1). The study lists 2 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 NCT01263223.

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 23 Oct 2018.