Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001482
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
New Drugs in the Treatment of Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Lamotrigine Lamictal Registered Trademark Monotherapy and Gabapentin Neurontin Registered Trademark Monotherapy in the Treatment of Mood Disorders
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1500 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
Detailed Description:
The anticonvulsants carbamazepine CBZ and valproate VPA have efficacy in the treatment of mood disorders suggesting that other anticonvulsants with related mechanisms of action may have similar utility Additional treatments are sorely needed because many patients with recurrent affective disorder have symptoms refractory to treatment with conventional agents including lithium carbamazepine and valproate This refractory group is the major focus of our investigative efforts on 3-west in the Section of Psychobiology NIMH Moreover establishing differential clinical and biological predictors of response has become increasingly important both to rapid allocation of appropriate treatment and as they may supply insight into the pathophysiology of the mood disorders and their subtypes
Lamotrigine a phenyltriazine use-dependent sodium channel blocker that inhibits release of excitatory amino acids is a new anticonvulsant with fewer side effects than older agents and was recently approved by the FDA as adjunctive therapy in the treatment of partial seizures Heretofore only preliminary open clinical evidence suggested that lamotrigine may have mood stabilizing properties
Gabapentin is a neutral amino acid and gamma-aminobutyric acid GABA analog which increases brain GABA levels and has fewer side effects than older agents and does not require hematological or hepatic monitoring Preliminary evidence only from open add-on series had suggested that gabapentin therapy might have antidepressant and antianxiety effects if not mood stabilizing properties
We wish to evaluate the efficacy of lamotrigine and gabapentin in the refractory mood disorders We also wish to examine the neurobiology and phenomenology of lamotrigine and gabapentin responders and nonresponders to ascertain potential predictors and concomitants of response to these medications This study may lead to improvement in the treatment and understanding of mood disorders by providing controlled data on efficacy of these potential new treatments potential predictors of response and further insights into the pathophysiology of mood disorders
Lamotrigine a phenyltriazine use-dependent sodium channel blocker that inhibits release of excitatory amino acids is a new anticonvulsant with fewer side effects than older agents and was recently approved by the FDA as adjunctive therapy in the treatment of partial seizures Heretofore only preliminary open clinical evidence suggested that lamotrigine may have mood stabilizing properties
Gabapentin is a neutral amino acid and gamma-aminobutyric acid GABA analog which increases brain GABA levels and has fewer side effects than older agents and does not require hematological or hepatic monitoring Preliminary evidence only from open add-on series had suggested that gabapentin therapy might have antidepressant and antianxiety effects if not mood stabilizing properties
We wish to evaluate the efficacy of lamotrigine and gabapentin in the refractory mood disorders We also wish to examine the neurobiology and phenomenology of lamotrigine and gabapentin responders and nonresponders to ascertain potential predictors and concomitants of response to these medications This study may lead to improvement in the treatment and understanding of mood disorders by providing controlled data on efficacy of these potential new treatments potential predictors of response and further insights into the pathophysiology of mood disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0115 | None | None | None |