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Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Information source: Institute of Social Security of the Civil Servants of Minas Gerais
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Lamotrigine (Drug); Amide (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Institute of Social Security of the Civil Servants of Minas Gerais

Official(s) and/or principal investigator(s):
Milena A Santos, Master, Principal Investigator, Affiliation: City Hall of Beló Horizonte
Claudia Hara, Master, Study Chair, Affiliation: Faculdade de Saúde e Ecologia Humana
Fabio L Rocha, PhD, Study Director, Affiliation: Institute of Social Security of the Civil Servants of Minas Gerais

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.

Clinical Details

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

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

Primary outcome: Montgomery and Asberg Scale for Depression

Secondary outcome: Clinical Global Impression

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

FDA, Overview of Lamotrigine

Related publications:

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.

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

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

Starting date: January 2004
Last updated: April 3, 2008

Page last updated: August 23, 2015

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