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Lamotrigine Augmentation in Resistant Depression

NCT00901407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2009-05-13

No results posted yet for this study

Summary

This study is intended to evaluate the efficacy and safety of lamotrigine as an antidepressant augmentation agent in a sample of individuals with major depression and a history of both prior non-response and prospective failure to respond to at least one adequate trial of an antidepressant (for a total of two failed trials).

Conditions

  • Unipolar Depression

Interventions

DRUG

lamotrigine

lamotrigine augmentation 25 to 100 mg tablets, 25 to 200 mg bid,10 weeks

DRUG

placebo

placebo: 1-2 tablets bid; 10 weeks

DRUG

paroxetine

open label paroxetine 10 to 50 mg, at bedtime for 18 weeks (8 weeks prior to randomization and 10 weeks after)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • James G. Barbee, MD · Louisiana State University Health Sciences Center in New Orleans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-07-31
Completion
2007-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901407 on ClinicalTrials.gov