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NCT01452919 · ClinicalTrials.gov registry record · Phase 3
A Physical Dependence Study in Schizophrenia
A Phase 3 study, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
NCT01452919: Completed Phase 3 study, sponsored by Denovo Biopharma.
NCT01452919 is a Phase 3 study that has completed, run by Denovo Biopharma. The registered enrollment target is 123 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01452919, a Phase 3 study, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it. This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.
Primary Outcome
The checklist is a 30-item, participant-rated scale that asks whether participants experience symptoms such as nausea, vomiting, loss of appetite, anxiety, irritability, or craving for study drug during the previous day to assess potential symptoms of drug withdrawal. Each item is rated on a 0 (not at all) to 3 (severe). Total scores range from 0-90. Higher scores indicate greater severity of symptoms. The 3-day MA was calculated starting the third day until the last day of double-blind, randomi
Interventions
- DRUG Placebo
- DRUG LY2140023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01452919 record still lists
NCT01452919 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01452919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01452919 about?
NCT01452919 is a clinical study titled "A Physical Dependence Study in Schizophrenia". The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it. This trial consists of two phases: An open-label phase consisting of...
What is the current status of trial NCT01452919?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01452919?
The interventions under investigation include: Placebo (DRUG), LY2140023 (DRUG).
Who is sponsoring clinical trial NCT01452919?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01452919's enrollment target sits among peer trials
123 1615th of 2000 higher than 384 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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