Depression
Conditions
Keywords
Treatment, Augmentation, Resistant depression, Lamotrigine
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.
Interventions
DRUGLamotrigine
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
DIETARY_SUPPLEMENTAmide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
Sponsors
Institute of Social Security of the Civil Servants of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery and Asberg Scale for Depression | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression | 8 weeks |
Outcome results
None listed