Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Depression Clinical Trial

Official title:

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652171
• Other study ID #: CEP: 093/03
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: April 3, 2008
• Start date: January 2004
• Est. completion date: January 2006

Study information

• Verified date: April 2008
• Source: Institute of Social Security of the Civil Servants of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (3)

Barbee JG, Jamhour NJ. Lamotrigine as an augmentation agent in treatment-resistant depression. J Clin Psychiatry. 2002 Aug;63(8):737-41. — View Citation

Barbosa L, Berk M, Vorster M. A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes. J Clin Psychiatry. 2003 Apr;64(4):403-7. — View Citation

Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery and Asberg Scale for Depression		8 weeks	Yes
Secondary	Clinical Global Impression		8 weeks	Yes

External Links

•   FDA, Overview of Lamotrigine