Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
Overview
- Phase
- Phase 3
- Intervention
- Lamotrigine
- Conditions
- Depression
- Sponsor
- Institute of Social Security of the Civil Servants of Minas Gerais
- Enrollment
- 34
- Primary Endpoint
- Montgomery and Asberg Scale for Depression
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
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.
Intervention: Lamotrigine
2
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.
Intervention: Amide
Outcomes
Primary Outcomes
Montgomery and Asberg Scale for Depression
Time Frame: 8 weeks
Secondary Outcomes
- Clinical Global Impression(8 weeks)