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Efficacy and Safety of Antidepressant Augmentation With Lamotrigine

This study has been completed.
Sponsor:
Information provided by:
Institute of Social Security of the Civil Servants of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00652171
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008

April 1, 2008
April 3, 2008
January 2004
January 2006   (final data collection date for primary outcome measure)
Montgomery and Asberg Scale for Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00652171 on ClinicalTrials.gov Archive Site
Clinical Global Impression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Depression
  • 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.
  • Active Comparator: 1
    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.
    Intervention: Drug: Lamotrigine
  • Placebo Comparator: 2
    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: Dietary Supplement: Amide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00652171
CEP: 093/03
Yes
Milena Antunes Santos/Dr, Post - Graduation in Health Sciences, IPSEMG
Institute of Social Security of the Civil Servants of Minas Gerais
Not Provided
Principal Investigator: Milena A Santos, Master City Hall of Beló Horizonte
Study Chair: Claudia Hara, Master Faculdade de Saúde e Ecologia Humana
Study Director: Fabio L Rocha, PhD Institute of Social Security of the Civil Servants of Minas Gerais
Institute of Social Security of the Civil Servants of Minas Gerais
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP