search
Back to results

Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lamotrigine
Amide
Sponsored by
Institute of Social Security of the Civil Servants of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Treatment, Augmentation, Resistant depression, Lamotrigine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Montgomery and Asberg Scale for Depression

    Secondary Outcome Measures

    Clinical Global Impression

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    April 3, 2008
    Sponsor
    Institute of Social Security of the Civil Servants of Minas Gerais
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00652171
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Institute of Social Security of the Civil Servants of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Treatment, Augmentation, Resistant depression, Lamotrigine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lamotrigine
    Intervention Description
    Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Amide
    Intervention Description
    Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
    Primary Outcome Measure Information:
    Title
    Montgomery and Asberg Scale for Depression
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Clinical Global Impression
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milena A Santos, Master
    Organizational Affiliation
    City Hall of Beló Horizonte
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Claudia Hara, Master
    Organizational Affiliation
    Faculdade de Saúde e Ecologia Humana
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fabio L Rocha, PhD
    Organizational Affiliation
    Institute of Social Security of the Civil Servants of Minas Gerais
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12716240
    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.
    Results Reference
    background
    PubMed Identifier
    12598821
    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.
    Results Reference
    background
    PubMed Identifier
    12197456
    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.
    Results Reference
    background
    PubMed Identifier
    18615166
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=LAMOTRIGINE
    Description
    FDA, Overview of Lamotrigine

    Learn more about this trial

    Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

    We'll reach out to this number within 24 hrs