| 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 |
| |
| 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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Depression |
- Drug: Lamotrigine
- Dietary Supplement: Amide
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- Active Comparator: 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.
- Placebo Comparator: 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.
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| Completed |
| 34 |
| January 2006 |
| January 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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
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| Both |
| 18 Years to 60 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00652171 |
| Milena Antunes Santos/Dr, Post - Graduation in Health Sciences, IPSEMG |
| CEP: 093/03 |
| Institute of Social Security of the Civil Servants of Minas Gerais |
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| Principal Investigator: |
Milena A Santos, Master |
City Hall of Beló Horizonte |
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| Study Chair: |
Claudia Hara, Master |
Faculdade de Saúde e Ecologia Humana |
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| Study Director: |
Fabio L Rocha, PhD |
Institute of Social Security of the Civil Servants of Minas Gerais |
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| Institute of Social Security of the Civil Servants of Minas Gerais |
| April 2008 |