Lamotrigine Augmentation in Resistant Depression

NCT00901407 | Completed DMC

• 1 other identifier: LMC-R93
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

augmentation; depression; resistance

Outcome Measures

Primary Outcomes (1)

• MADRS score

  weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18, and 20

Secondary Outcomes (2)

• Ham-D score

  weeks 0 (randomization); 2, 4, 6, 8, 9, 10, 12, 14, 16, and 18

• CGI-S and CGI-I

  weeks 0 (randomization); 8, 9, 10, 12, 14, 16, 18 and 20

Study Arms (2)

1

EXPERIMENTAL

lamotrigine

Drug: lamotrigine; Drug: paroxetine

2

PLACEBO COMPARATOR

placebo

Drug: placebo; Drug: paroxetine

Interventions

lamotrigine DRUG

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

Also known as: Lamictal

1

placebo DRUG

placebo: 1-2 tablets bid; 10 weeks

2

paroxetine DRUG

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

Also known as: paxil

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age 18-65
• A current primary diagnosis of unipolar major depression based on certain criteria
• Have a score of \> 18 on the 17-item Hamilton Depression scale
• A history of prior failure of at least one adequate trial of an FDA-approved antidepressant. The antidepressant failure must have occurred within the current episode of major depression
• Females of childbearing potential will be allowed as long as they are taking adequate contraceptive precautions

You may not qualify if:

• A primary Axis I diagnosis other than primary unipolar major depression
• A history suggestive of hypomania or mania during the current episode or during the person's lifetime
• A history of psychosis, dementia, organic affective disorders or alcohol and/or substance abuse in the previous six months
• Individuals with a current or past diagnosis of schizoid, schizotypal, borderline or antisocial or any other current or past severe personality disorder
• Individuals with a current or past diagnosis of schizophrenia or schizoaffective disorder
• A history of failure to respond to electroconvulsive therapy during the current or any prior lifetime episode of major depression
• A history of failure of a prior adequate trial of paroxetine or paroxetine-CR for the treatment of Major Depression
• Significant, coexisting medical conditions that might make it unsafe to take either of the study medications, or in which any average reasonable clinician would assume that the medical condition may, in fact, be exacerbating the current episode of depression or impede the person's ability to recover fully from their depressive illness
• Presence of significant medical abnormalities on baseline laboratory values or physical examination, including vital signs
• Individuals with any significant abnormalities of thyroid function
• Subjects on thyroid supplementation must have been on a stable dose for six months prior to the screening visit
• Individuals who will require concomitant psychotropic medications, including benzodiazepines
• Subjects with severe insomnia will be allowed to take a maximum of 10 mg of zolpidem on two nights weekly at the investigator's discretion.
• Zolpidem may not be taken on the night before the study visit.
• Each dose of zolpidem should be listed on the concurrent medication case report form

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

LSUHSC- New Orleans

New Orleans, Louisiana, 70115, United States

Location

Related Publications (3)

• Barbee, J.G., Jamhour, N,J., Stewart, J.W., Shelton, R.C., Reimherr, F.W., Thompson, P.M., Conrad, E.J. &Thompson, T.R. (2007, May). Lamotrigine as an antidepressant augmentation in treatment refractory unipolar depression. Poster session presented at the annual meeting of the American Psychiatric Association, San Diego, CA.

  RESULT

• Barbee, J.G., Jamhour, N,J. & Conrad, E.J. (2007, June). Predictors of response to lamotrigine augmentation in treatment refractory unipolar depression. Poster session presented at the annual meeting of the New Clinical Drug Evaluation Unit, Boca Raton, FL.

  RESULT

• Barbee JG, Thompson TR, Jamhour NJ, Stewart JW, Conrad EJ, Reimherr FW, Thompson PM, Shelton RC. A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. J Clin Psychiatry. 2011 Oct;72(10):1405-12. doi: 10.4088/JCP.09m05355gre.

  PMID: 21367355 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Lamotrigine; Paroxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• James G. Barbee, MD

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: December 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: April 1, 2007
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

US (1)