Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Social Security of the Civil Servants of Minas Gerais
• Treatments: Anticonvulsants; Antidepressive Agents; Lamotrigine

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