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NCT01051440 · ClinicalTrials.gov registry record · Phase 4
Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression
A Phase 4 study, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT01051440: Clinical Trial Phase 4 study, sponsored by Steward St. Elizabeth's Medical Center of Boston.
NCT01051440 is a Phase 4 study that was terminated before completion, run by Steward St. Elizabeth's Medical Center of Boston. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01051440, a Phase 4 study, was terminated before completion, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the study drug or placebo in addition to a mood stabilizer. The study includes functional magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the medication alters the response to affective stimuli or glutamate, glutamine, or gamma aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine whether the study drug improves memory and attention in this population. The primary hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary hypothesis is that it will result in an increased response to affective stimuli and altered neurotransmitter levels in the anterior cingulate cortex.
Primary Outcome
The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
Why NCT01051440 stopped before completion
NCT01051440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01051440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01051440 about?
NCT01051440 is a clinical study titled "Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression". There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention ...
What is the current status of trial NCT01051440?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2010-02. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01051440?
The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT01051440?
This trial is sponsored by Steward St. Elizabeth's Medical Center of Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01051440's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 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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