Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001482
Other study ID # 950115
Secondary ID 95-M-0115
Status Completed
Phase Phase 2
First received November 3, 1999
Last updated March 3, 2008
Start date May 1995
Est. completion date May 2001

Study information

Verified date June 2000
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.)

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Intervention

Drug:
Lamotrigine (Lamictal® (Registered Trademark)

Gabapentin (Neurontin® (Registered Trademark))


Locations

Country Name City State
United States National Institute of Mental Health (NIMH) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Not yet recruiting NCT03224845 - Courageous Parents, Courageous Children N/A
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT02145429 - Preventing Depression in Late Life: A Model for Low and Middle Income Countries N/A
Completed NCT00794456 - Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety Phase 3
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00252343 - Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder Phase 3
Not yet recruiting NCT05867823 - OcupApp: Occupational Self-analysis Intervention Through an Mobile Application N/A
Recruiting NCT04562324 - Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder N/A
Recruiting NCT05989451 - Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders N/A
Not yet recruiting NCT05488418 - Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56 N/A
Not yet recruiting NCT03608449 - Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System N/A
Completed NCT03400397 - An Effectiveness Study of the Cool Kids Programme N/A
Completed NCT00025844 - Fear Conditioning Using Computer-Generated Virtual Reality N/A
Completed NCT02579928 - Ketamine Infusion for Adolescent Depression and Anxiety Phase 4
Completed NCT02270073 - The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Completed NCT01721824 - The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders N/A
Completed NCT01425619 - The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests N/A
Completed NCT01227980 - Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^ Phase 2