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
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