Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

• ClinicalTrials.gov Identifier: NCT00652171
• Recruitment Status: Completed
• First Posted: April 3, 2008
• Last Update Posted: April 9, 2008
• Sponsor: 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

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Depression	Drug: Lamotrigine; Dietary Supplement: Amide	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
• Study Start Date: January 2004
• Actual Primary Completion Date: January 2006
• Actual Study Completion Date: January 2006

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; 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.
Placebo Comparator: 2; 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.

Outcome Measures

Primary Outcome Measures :

1. Montgomery and Asberg Scale for Depression [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Clinical Global Impression [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Santos MA, Rocha FL, Hara C. Efficacy and safety of antidepressant augmentation with lamotrigine in patients with treatment-resistant depression: a randomized, placebo-controlled, double-blind study. Prim Care Companion J Clin Psychiatry. 2008;10(3):187-90.

• Responsible Party: Milena Antunes Santos/Dr, Post - Graduation in Health Sciences, IPSEMG
• ClinicalTrials.gov Identifier: NCT00652171
• Other Study ID Numbers: CEP: 093/03
• First Posted: April 3, 2008
• Last Update Posted: April 9, 2008
• Last Verified: April 2008

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

Treatment; Augmentation; Resistant depression; Lamotrigine

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Lamotrigine; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Sodium Channel Blockers