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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