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NCT00001482 · ClinicalTrials.gov registry record · Phase 2
New Drugs in the Treatment of Mood Disorders
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00001482 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 60 participants.
The verdict
NCT00001482, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
Interventions
- DRUG Lamotrigine (Lamictal® (Registered Trademark)
- DRUG Gabapentin (Neurontin® (Registered Trademark))
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1995-05 |
| Est. Completion | 2001-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001482
The ClinicalTrials.gov registry entry for NCT00001482 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine (Lamictal® (Registered Trademark) is the first listed.
NCT00001482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001482 about?
NCT00001482 is a clinical study titled "New Drugs in the Treatment of Mood Disorders". This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or place...
What is the current status of trial NCT00001482?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 1995-05. Estimated completion is 2001-05.
What interventions are being tested in trial NCT00001482?
The interventions under investigation include: Lamotrigine (Lamictal® (Registered Trademark) (DRUG), Gabapentin (Neurontin® (Registered Trademark)) (DRUG).
Who is sponsoring clinical trial NCT00001482?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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