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A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression.
J Clin Psychiatry 2011; 72(10):1405-12JC

Abstract

BACKGROUND

Previous reports have suggested that lamotrigine is effective as an antidepressant augmentation agent in patients with treatment-resistant unipolar depression. This study is the largest double-blind placebo-controlled study conducted to date of lamotrigine in this role.

METHOD

In this multicenter trial, conducted at 19 sites, patients aged 18-65 years with a DSM-IV/ICD-10 diagnosis of unipolar, nonpsychotic major depressive disorder (confirmed by the Mini-International Neuropsychiatric Interview) who had failed at least 1 adequate trial of an antidepressant (N = 183) were first treated for 8 weeks with open-label paroxetine or paroxetine controlled-release in dosages up to 50 mg/d or 62.5 mg/d, respectively. Individuals with a 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 15 (n = 96) were then randomized on a double-blind basis to receive either placebo or lamotrigine in dosages titrated upward to a maximum of 400 mg/d for 10 weeks. Sixty-five patients completed the study. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS), and the main secondary outcome measures were the HDRS-17 and Clinical Global Impressions-Severity of Illness (CGI-S) and Clinical Global Impressions-Improvement (CGI-I) ratings. Data were collected from 2003 to 2006.

RESULTS

Results of the primary efficacy analysis of the randomized patients using the MADRS, HDRS-17, CGI-S, and CGI-I did not demonstrate a statistically significant difference between lamotrigine and placebo groups, although some secondary analyses were suggestive of efficacy, particularly in those patients who completed the study (completer analysis) and in more severely ill patients (HDRS-17 ≥ 25).

CONCLUSIONS

This add-on study of patients with treatment-resistant depression failed to detect a statistically significant difference between lamotrigine and placebo given for 10 weeks. However, post hoc analyses suggest that future studies of lamotrigine's efficacy might focus on specific subgroups with depression.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00901407.

Authors+Show Affiliations

Department of Psychiatry, Louisiana State University Health Sciences Center, New Orleans, LA, USA. jgbmd@att.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21367355

Citation

Barbee, James G., et al. "A Double-blind Placebo-controlled Trial of Lamotrigine as an Antidepressant Augmentation Agent in Treatment-refractory Unipolar Depression." The Journal of Clinical Psychiatry, vol. 72, no. 10, 2011, pp. 1405-12.
Barbee JG, Thompson TR, Jamhour NJ, et al. A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. J Clin Psychiatry. 2011;72(10):1405-12.
Barbee, J. G., Thompson, T. R., Jamhour, N. J., Stewart, J. W., Conrad, E. J., Reimherr, F. W., ... Shelton, R. C. (2011). A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. The Journal of Clinical Psychiatry, 72(10), pp. 1405-12. doi:10.4088/JCP.09m05355gre.
Barbee JG, et al. A Double-blind Placebo-controlled Trial of Lamotrigine as an Antidepressant Augmentation Agent in Treatment-refractory Unipolar Depression. J Clin Psychiatry. 2011;72(10):1405-12. PubMed PMID: 21367355.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. AU - Barbee,James G, AU - Thompson,Thomas R, AU - Jamhour,Nowal J, AU - Stewart,Jonathan W, AU - Conrad,Erich J, AU - Reimherr,Frederick W, AU - Thompson,Peter M, AU - Shelton,Richard C, PY - 2009/05/08/received PY - 2010/04/06/accepted PY - 2011/3/4/entrez PY - 2011/3/4/pubmed PY - 2012/1/6/medline SP - 1405 EP - 12 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 72 IS - 10 N2 - BACKGROUND: Previous reports have suggested that lamotrigine is effective as an antidepressant augmentation agent in patients with treatment-resistant unipolar depression. This study is the largest double-blind placebo-controlled study conducted to date of lamotrigine in this role. METHOD: In this multicenter trial, conducted at 19 sites, patients aged 18-65 years with a DSM-IV/ICD-10 diagnosis of unipolar, nonpsychotic major depressive disorder (confirmed by the Mini-International Neuropsychiatric Interview) who had failed at least 1 adequate trial of an antidepressant (N = 183) were first treated for 8 weeks with open-label paroxetine or paroxetine controlled-release in dosages up to 50 mg/d or 62.5 mg/d, respectively. Individuals with a 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 15 (n = 96) were then randomized on a double-blind basis to receive either placebo or lamotrigine in dosages titrated upward to a maximum of 400 mg/d for 10 weeks. Sixty-five patients completed the study. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS), and the main secondary outcome measures were the HDRS-17 and Clinical Global Impressions-Severity of Illness (CGI-S) and Clinical Global Impressions-Improvement (CGI-I) ratings. Data were collected from 2003 to 2006. RESULTS: Results of the primary efficacy analysis of the randomized patients using the MADRS, HDRS-17, CGI-S, and CGI-I did not demonstrate a statistically significant difference between lamotrigine and placebo groups, although some secondary analyses were suggestive of efficacy, particularly in those patients who completed the study (completer analysis) and in more severely ill patients (HDRS-17 ≥ 25). CONCLUSIONS: This add-on study of patients with treatment-resistant depression failed to detect a statistically significant difference between lamotrigine and placebo given for 10 weeks. However, post hoc analyses suggest that future studies of lamotrigine's efficacy might focus on specific subgroups with depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00901407. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/21367355/A_double_blind_placebo_controlled_trial_of_lamotrigine_as_an_antidepressant_augmentation_agent_in_treatment_refractory_unipolar_depression_ L2 - http://www.psychiatrist.com/jcp/article/pages/2011/v72n10/v72n1016.aspx DB - PRIME DP - Unbound Medicine ER -