Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Phase 3

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: Amide; Drug: Lamotrigine

• Registration Number: NCT00652171
• Lead Sponsor: Institute of Social Security of the Civil Servants of Minas Gerais

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.

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Last Update Submitted: 2008-04-03
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Amide	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.
1	Lamotrigine	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.

Primary Outcome Measures

Name	Time	Method
Montgomery and Asberg Scale for Depression	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression	8 weeks