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NCT01263223 · ClinicalTrials.gov registry record · Phase 1
A Study of LY2216684 in Major Depressive Disorder in Patients Taking Selective Serotonin Reuptake Inhibitors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01263223: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01263223 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263223, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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, an
Interventions
- DRUG Placebo
- DRUG LY2216684
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01263223 record still lists
NCT01263223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01263223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263223 about?
NCT01263223 is a clinical study titled "A Study of LY2216684 in Major Depressive Disorder in Patients Taking 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...
What is the current status of trial NCT01263223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-12. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01263223?
The interventions under investigation include: Placebo (DRUG), LY2216684 (DRUG).
Who is sponsoring clinical trial NCT01263223?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01263223's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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