Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
NCT ID: NCT00652171
Last Updated: 2008-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
34 participants
INTERVENTIONAL
2004-01-31
2006-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
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.
Amide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
Interventions
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Lamotrigine
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
Amide
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
Eligibility Criteria
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Inclusion Criteria
* 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
* psychosis
* and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs
18 Years
60 Years
ALL
No
Sponsors
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Institute of Social Security of the Civil Servants of Minas Gerais
OTHER_GOV
Responsible Party
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Post - Graduation in Health Sciences, IPSEMG
Principal Investigators
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Milena A Santos, Master
Role: PRINCIPAL_INVESTIGATOR
City Hall of Beló Horizonte
Claudia Hara, Master
Role: STUDY_CHAIR
Faculdade de Saúde e Ecologia Humana
Fabio L Rocha, PhD
Role: STUDY_DIRECTOR
Institute of Social Security of the Civil Servants of Minas Gerais
References
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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.
Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9. doi: 10.1097/00004850-200303000-00006.
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.
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.
Related Links
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FDA, Overview of Lamotrigine
Other Identifiers
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CEP: 093/03
Identifier Type: -
Identifier Source: org_study_id