Clinical trial NCT00652171: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
Official title: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Treatment
Augmentation
Resistant depression
Lamotrigine
Lead sponsor: Institute of Social Security of the Civil Servants of Minas Gerais
Sponsor class: OTHER_GOV
First posted: 2008-04-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Montgomery and Asberg Scale for Depression
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: City Hall of Beló Horizonte
name: Milena A Santos, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Saúde e Ecologia Humana
name: Claudia Hara, Master
role: STUDY_CHAIR
affiliation: Institute of Social Security of the Civil Servants of Minas Gerais
name: Fabio L Rocha, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.4088/jcp.v64n0407.
citation: Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9. doi: 10.1097/00004850-200303000-00006.
citation: Barbee JG, Jamhour NJ. Lamotrigine as an augmentation agent in treatment-resistant depression. J Clin Psychiatry. 2002 Aug;63(8):737-41. doi: 10.4088/jcp.v63n0813.
citation: Santos MA, Rocha FL, Hara C. Efficacy and safety of antidepressant augmentation with lamotrigine in patients with treatment-resistant depression: a randomized, placebo-controlled, double-blind study. Prim Care Companion J Clin Psychiatry. 2008;10(3):187-90. doi: 10.4088/pcc.v10n0302.