Status:

COMPLETED

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Lead Sponsor:

Institute of Social Security of the Civil Servants of Minas Gerais

Conditions:

Depression

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

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 th...

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 evi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2006

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00652171

Start Date

January 1 2004

End Date

January 1 2006

Last Update

April 9 2008

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