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Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study
Objective: To evaluate the effect of 32-mg/d naltrexone sustained release and 360-mg/d bupropion sustained release (NB32) in overweight and obese patients with major depressive disorder (MDD). Method: Twenty-five female patients with a DSM-IV diagnosis of MDD, an Inventory of Depressive Symptomatolo...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Physicians Postgraduate Press, Inc.
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795584/ https://www.ncbi.nlm.nih.gov/pubmed/24171147 http://dx.doi.org/10.4088/PCC.12m01494 |
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author | McElroy, Susan L. Guerdjikova, Anna I. Kim, Dennis D. Burns, Colleen Harris-Collazo, Raúl Landbloom, Ronald Dunayevich, Eduardo |
author_facet | McElroy, Susan L. Guerdjikova, Anna I. Kim, Dennis D. Burns, Colleen Harris-Collazo, Raúl Landbloom, Ronald Dunayevich, Eduardo |
author_sort | McElroy, Susan L. |
collection | PubMed |
description | Objective: To evaluate the effect of 32-mg/d naltrexone sustained release and 360-mg/d bupropion sustained release (NB32) in overweight and obese patients with major depressive disorder (MDD). Method: Twenty-five female patients with a DSM-IV diagnosis of MDD, an Inventory of Depressive Symptomatology—Self-Report score > 26, and a body mass index ≥ 27 and ≤ 43 kg/m(2) received up to 24 weeks of open-label treatment with NB32 with dietary and behavioral counseling (data collection: March 2008–July 2009). The primary endpoint was change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks; secondary endpoints included MADRS total score at week 24, change in weight, and Clinical Global Impressions–Improvement scale responder status (CGI-I score ≤ 2) at weeks 12 and 24 (modified intent-to-treat [mITT]: patients with ≥ 1 postbaseline MADRS total score on study drug; N = 23). Results: MADRS scores showed significant reductions at weeks 12 and 24 (mITT–last observation carried forward [LOCF]: –13.1 ± 7.1 and –15.3 ± 8.1, respectively, P < .001 vs baseline for all). Mean ± SD weight loss was –4.0% ± 4.6% (mITT-LOCF) and –6.1% ± 4.7% (observed cases) at week 12 and –5.3% ± 6.5% (mITT-LOCF) and –9.2% ± 6.2% (observed cases) at week 24 (P < .001 vs baseline for all). By week 24, 95% of patients (mITT-LOCF) were responders (CGI-I score ≤ 2) and 70% were in remission (CGI-I score = 1). The safety/tolerability profile of NB32 was consistent with its individual components; the most common adverse events were nausea, constipation, headache, and insomnia, with no serious adverse events attributed to NB32. Conclusion: Twenty-four weeks of open-label NB32 therapy with dietary and behavioral counseling was associated with improvement in depressive symptoms and reduced body weight in overweight/obese women with MDD. Trial Registration: ClinicalTrials.gov Identifier: NCT00624858 |
format | Online Article Text |
id | pubmed-3795584 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Physicians Postgraduate Press, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-37955842013-10-29 Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study McElroy, Susan L. Guerdjikova, Anna I. Kim, Dennis D. Burns, Colleen Harris-Collazo, Raúl Landbloom, Ronald Dunayevich, Eduardo Prim Care Companion CNS Disord Articles Objective: To evaluate the effect of 32-mg/d naltrexone sustained release and 360-mg/d bupropion sustained release (NB32) in overweight and obese patients with major depressive disorder (MDD). Method: Twenty-five female patients with a DSM-IV diagnosis of MDD, an Inventory of Depressive Symptomatology—Self-Report score > 26, and a body mass index ≥ 27 and ≤ 43 kg/m(2) received up to 24 weeks of open-label treatment with NB32 with dietary and behavioral counseling (data collection: March 2008–July 2009). The primary endpoint was change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks; secondary endpoints included MADRS total score at week 24, change in weight, and Clinical Global Impressions–Improvement scale responder status (CGI-I score ≤ 2) at weeks 12 and 24 (modified intent-to-treat [mITT]: patients with ≥ 1 postbaseline MADRS total score on study drug; N = 23). Results: MADRS scores showed significant reductions at weeks 12 and 24 (mITT–last observation carried forward [LOCF]: –13.1 ± 7.1 and –15.3 ± 8.1, respectively, P < .001 vs baseline for all). Mean ± SD weight loss was –4.0% ± 4.6% (mITT-LOCF) and –6.1% ± 4.7% (observed cases) at week 12 and –5.3% ± 6.5% (mITT-LOCF) and –9.2% ± 6.2% (observed cases) at week 24 (P < .001 vs baseline for all). By week 24, 95% of patients (mITT-LOCF) were responders (CGI-I score ≤ 2) and 70% were in remission (CGI-I score = 1). The safety/tolerability profile of NB32 was consistent with its individual components; the most common adverse events were nausea, constipation, headache, and insomnia, with no serious adverse events attributed to NB32. Conclusion: Twenty-four weeks of open-label NB32 therapy with dietary and behavioral counseling was associated with improvement in depressive symptoms and reduced body weight in overweight/obese women with MDD. Trial Registration: ClinicalTrials.gov Identifier: NCT00624858 Physicians Postgraduate Press, Inc. 2013 2013-06-20 /pmc/articles/PMC3795584/ /pubmed/24171147 http://dx.doi.org/10.4088/PCC.12m01494 Text en Copyright © 2013, Physicians Postgraduate Press, Inc. Open Access Article |
spellingShingle | Articles McElroy, Susan L. Guerdjikova, Anna I. Kim, Dennis D. Burns, Colleen Harris-Collazo, Raúl Landbloom, Ronald Dunayevich, Eduardo Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title | Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title_full | Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title_fullStr | Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title_full_unstemmed | Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title_short | Naltrexone/Bupropion Combination Therapy in Overweight or Obese Patients With Major Depressive Disorder: Results of a Pilot Study |
title_sort | naltrexone/bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795584/ https://www.ncbi.nlm.nih.gov/pubmed/24171147 http://dx.doi.org/10.4088/PCC.12m01494 |
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