Efficacy and Safety of Antidepressant Augmentation With Lamotrigine - Full Text View

Sponsored by:	Institute of Social Security of the Civil Servants of Minas Gerais
Information provided by:	Institute of Social Security of the Civil Servants of Minas Gerais
ClinicalTrials.gov Identifier:	NCT00652171

Purpose

This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.

Condition	Intervention	Phase
Depression	Drug: Lamotrigine Dietary Supplement: Amide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by Institute of Social Security of the Civil Servants of Minas Gerais:

Primary Outcome Measures:

Montgomery and Asberg Scale for Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Global Impression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	January 2004
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 17 Patients - Mean age of 26 years old, 14 female and 3 male - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.	Drug: Lamotrigine Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
2: Placebo Comparator 17 Patients - 11 females and 6 males mean age of 29 years old - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.	Dietary Supplement: Amide Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.

Arms

Assigned Interventions

1: Active Comparator

17 Patients - Mean age of 26 years old, 14 female and 3 male - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.

Drug: Lamotrigine

Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.

2: Placebo Comparator

17 Patients - 11 females and 6 males mean age of 29 years old - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms.

Dietary Supplement: Amide

Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.

Detailed Description:

Objective: This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.

Method: A double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients who had DSM-IV major depressive disorder and were resistant to at least 2 antidepressants. The subjects were on taking antidepressant therapy and were randomly assigned to receive placebo or lamotrigine as an adjunct therapy for 8 weeks. They were evaluated on a biweekly basis in order to access assess the efficacy and the safety of the drug.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

They were selected according to a clinical interview based on DSM-IV criteria for major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides
They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11
- failure to respond to treatment with at least 2 antidepressants of different classes
- at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms

Exclusion Criteria:

Pregnant or lactating women or those capable of getting pregnant that who were not using contraceptive methods were excluded as well as patients with severe clinical diseases or organic mental disorder
Further exclusion criteria were acute depression with risk of suicide
psychosis
and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652171

Sponsors and Collaborators

Institute of Social Security of the Civil Servants of Minas Gerais

Investigators

Principal Investigator:	Milena A Santos, Master	City Hall of Beló Horizonte
Study Chair:	Claudia Hara, Master	Faculdade de Saúde e Ecologia Humana
Study Director:	Fabio L Rocha, PhD	Institute of Social Security of the Civil Servants of Minas Gerais

More Information

Additional Information:

FDA, Overview of Lamotrigine This link exits the ClinicalTrials.gov site

Publications:

Barbosa L, Berk M, Vorster M. A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes. J Clin Psychiatry. 2003 Apr;64(4):403-7.

Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9.

Barbee JG, Jamhour NJ. Lamotrigine as an augmentation agent in treatment-resistant depression. J Clin Psychiatry. 2002 Aug;63(8):737-41.

Responsible Party:	Post - Graduation in Health Sciences, IPSEMG ( Milena Antunes Santos/Dr )
Study ID Numbers:	CEP: 093/03
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00652171 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Institute of Social Security of the Civil Servants of Minas Gerais:

Treatment
Augmentation
Resistant depression
Lamotrigine

Study placed in the following topic categories:

Calcium, Dietary
Depression
Mental Disorders
Psychotropic Drugs
Lamotrigine
Mood Disorders

Calcium Channel Blockers
Cardiovascular Agents
Depressive Disorder
Anticonvulsants
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs
Calcium Channel Blockers
Cardiovascular Agents
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms

Membrane Transport Modulators
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009