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NCT01134731 · ClinicalTrials.gov registry record · Phase 4
Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT01134731: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT01134731 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 54 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134731, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects. Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.
Primary Outcome
The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.
Interventions
- DRUG Placebo
- DRUG paliperidone
- DRUG lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT01134731 record still lists
NCT01134731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01134731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01134731 about?
NCT01134731 is a clinical study titled "Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation". The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus l...
What is the current status of trial NCT01134731?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2010-05. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01134731?
The interventions under investigation include: Placebo (DRUG), paliperidone (DRUG), lithium (DRUG).
Who is sponsoring clinical trial NCT01134731?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01134731's enrollment target sits among peer trials
54 1223rd of 2000 higher than 772 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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