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NCT01223001 · ClinicalTrials.gov registry record · Phase 2
Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
A Phase 2 study, sponsored by Rehabilitation Hospital of Indiana.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01223001: Clinical Trial Phase 2 study, sponsored by Rehabilitation Hospital of Indiana.
NCT01223001 is a Phase 2 study that was terminated before completion, run by Rehabilitation Hospital of Indiana. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01223001, a Phase 2 study, was terminated before completion, sponsored by Rehabilitation Hospital of Indiana.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.
Primary Outcome
To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.
Interventions
- DRUG Duloxetine
- DRUG Sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 1996-09 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Why NCT01223001 stopped before completion
NCT01223001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Duloxetine is the first listed.
NCT01223001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01223001 about?
NCT01223001 is a clinical study titled "Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury". The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.
What is the current status of trial NCT01223001?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 1996-09. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01223001?
The interventions under investigation include: Duloxetine (DRUG), Sugar pill (DRUG).
Who is sponsoring clinical trial NCT01223001?
This trial is sponsored by Rehabilitation Hospital of Indiana, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01223001's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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