Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Institute of Social Security of the Civil Servants of Minas Gerais34 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Depression

Interventions

LamotrigineDRUG

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

AmideDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Montgomery and Asberg Scale for Depression

Time frame: 8 weeks

Secondary Outcomes

Clinical Global Impression

Time frame: 8 weeks

Data from ClinicalTrials.gov

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