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Sponsored by: |
Institute of Social Security of the Civil Servants of Minas Gerais |
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Information provided by: | Institute of Social Security of the Civil Servants of Minas Gerais |
ClinicalTrials.gov Identifier: | NCT00652171 |
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.
Condition | Intervention | Phase |
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Depression |
Drug: Lamotrigine Dietary Supplement: Amide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression |
Enrollment: | 34 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: 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.
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Drug: Lamotrigine
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
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2: 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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Dietary Supplement: Amide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11
Exclusion Criteria:
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 |
Responsible Party: | Post - Graduation in Health Sciences, IPSEMG ( Milena Antunes Santos/Dr ) |
Study ID Numbers: | CEP: 093/03 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652171 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Treatment Augmentation Resistant depression Lamotrigine |
Calcium, Dietary Depression Mental Disorders Lamotrigine |
Mood Disorders Depressive Disorder Behavioral Symptoms |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |