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NCT00621842 · ClinicalTrials.gov registry record · Phase 3
Lamotrigine for Symptoms of Geriatric Bipolar Depression
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
NCT00621842 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 57 participants.
The verdict
NCT00621842, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
Interventions
- DRUG Lamotrigine regular tablet formulation
- DRUG Lamotrigine novel formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00621842
The ClinicalTrials.gov registry entry for NCT00621842 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine regular tablet formulation is the first listed.
NCT00621842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00621842 about?
NCT00621842 is a clinical study titled "Lamotrigine for Symptoms of Geriatric Bipolar Depression". This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders ...
What is the current status of trial NCT00621842?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2008-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00621842?
The interventions under investigation include: Lamotrigine regular tablet formulation (DRUG), Lamotrigine novel formulation (DRUG).
Who is sponsoring clinical trial NCT00621842?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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