A Phase 3 interventional study of Lamotrigine and Amide in Depression, sponsored by Institute of Social Security of the Civil Servants of Minas Gerais. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-04-09.
Sponsored by Institute of Social Security of the Civil Servants of Minas Gerais · Phase 3, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 34 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Institute of Social Security of the Civil Servants of Minas Gerais as lead sponsor.
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They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11
Exclusion Criteria:
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.
Drug: Lamotrigine
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.
Dietary Supplement: Amide
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
Montgomery and Asberg Scale for Depression
Time frame: 8 weeks
Clinical Global Impression
Time frame: 8 weeks
No study locations are listed for this record.
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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