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NCT01042496 · ClinicalTrials.gov registry record · Phase 3
Bipolar Depression Before and After Lamotrigine Treatment
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT01042496: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT01042496 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01042496, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study compared glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine. The goal of this study was to better understand the neurobiology of bipolar depression and how lamotrigine may therapeutically impact brain function and mood response. The hypothesis was that in comparison to non-remission participants, bipolar participants who achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score \<12 at week 12) associated with lamotrigine monotherapy will exhibit a greater decrease in glutamate (Glu) and an increase in N-acetyl aspartate (NAA), reported as a cerebrospinal fluid (CSF)-corrected absolute concentration percent change from baseline to endpoint in anterior cingulate (AC) and dorsolateral prefrontal cortex (DLPFC).
Interventions
- DRUG Lamotrigine
- PROCEDURE 1H-MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01042496
The ClinicalTrials.gov registry entry for NCT01042496 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine is the first listed.
NCT01042496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01042496 about?
NCT01042496 is a clinical study titled "Bipolar Depression Before and After Lamotrigine Treatment". This study compared glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week c...
What is the current status of trial NCT01042496?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2009-12. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01042496?
The interventions under investigation include: Lamotrigine (DRUG), 1H-MR (PROCEDURE).
Who is sponsoring clinical trial NCT01042496?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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