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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 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.
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.
Interventions
- DRUG Placebo
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01051440
The ClinicalTrials.gov registry entry for NCT01051440 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steward St. Elizabeth's Medical Center of Boston, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01051440 reports 0 study locations.
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.
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