New Drugs in the Treatment of Mood Disorders
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorder; Mood Disorder; Psychotic Disorder
Intervention: Lamotrigine (Lamictal® (Registered Trademark) (Drug); Gabapentin (Neurontin® (Registered Trademark)) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH)
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.
Clinical Details
Official title: Evaluation of Lamotrigine (Lamictal® (Registered Trademark)) Monotherapy and Gabapentin (Neurontin® (Registered Trademark)) Monotherapy in the Treatment of Mood Disorders
Study design: Treatment, Safety/Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Patients between the ages of 18 and 75 who satisfy DSM-III-R criteria for mood disorders,
are refractory to at least two conventional treatments, and are inpatients or outpatients
at the NIMH are invited to participate provided that the following criteria are fulfilled:
Subjects having serious medical illness (or meeting current psychoactive substance
dependence will be excluded from entry.)
Locations and Contacts
National Institute of Mental Health (NIMH), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Frye MA, Ketter TA, Kimbrell TA, Dunn RT, Speer AM, Osuch EA, Luckenbaugh DA, Cora-Ocatelli G, Leverich GS, Post RM. A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders. J Clin Psychopharmacol. 2000 Dec;20(6):607-14.
Starting date: May 1995
Ending date: May 2001
Last updated: March 3, 2008
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