Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00652171|
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Lamotrigine Dietary Supplement: Amide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
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.
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
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.
Dietary Supplement: Amide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
- Montgomery and Asberg Scale for Depression [ Time Frame: 8 weeks ]
- Clinical Global Impression [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652171
|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|