Official Title: “Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine
  • Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
• Dietary Supplement: Amide
  • Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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.
• Placebo Comparator: 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.

Primary Measures

• Montgomery and Asberg Scale for Depression
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Secondary Measures

• Clinical Global Impression
  • Time Frame: 8 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Institute of Social Security of the Civil Servants of Minas Gerais

Overall Clinical Trial Officials and Contacts

Milena A Santos, Master Principal Investigator City Hall of Beló Horizonte  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652171

Study ID Number: CEP: 093/03

ClinicalTrials.gov Identifier: NCT00652171

Health Authority: Brazil: National Committee of Ethics in Research

FDA, Overview of Lamotrigine