Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial.
<h4>Objective</h4>To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington's disease (HD).<h4>Methods</h4>In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy acc...
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Public Library of Science (PLoS)
2017-01-01
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| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0173872&type=printable |
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| author | Harald Gelderblom Torsten Wüstenberg Tim McLean Lisanne Mütze Wilhelm Fischer Carsten Saft Rainer Hoffmann Sigurd Süssmuth Peter Schlattmann Erik van Duijn Bernhard Landwehrmeyer Josef Priller |
| author_facet | Harald Gelderblom Torsten Wüstenberg Tim McLean Lisanne Mütze Wilhelm Fischer Carsten Saft Rainer Hoffmann Sigurd Süssmuth Peter Schlattmann Erik van Duijn Bernhard Landwehrmeyer Josef Priller |
| author_sort | Harald Gelderblom |
| collection | DOAJ |
| description | <h4>Objective</h4>To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington's disease (HD).<h4>Methods</h4>In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy-Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI).<h4>Results</h4>At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator.<h4>Conclusion</h4>Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD.<h4>Trial registration</h4>ClinicalTrials.gov 01914965. |
| format | Article |
| id | doaj-art-d0801b228a5d4836b4bc2c490065a9e1 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2017-01-01 |
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| spelling | doaj-art-d0801b228a5d4836b4bc2c490065a9e12025-08-20T02:03:08ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01123e017387210.1371/journal.pone.0173872Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial.Harald GelderblomTorsten WüstenbergTim McLeanLisanne MützeWilhelm FischerCarsten SaftRainer HoffmannSigurd SüssmuthPeter SchlattmannErik van DuijnBernhard LandwehrmeyerJosef Priller<h4>Objective</h4>To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington's disease (HD).<h4>Methods</h4>In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy-Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI).<h4>Results</h4>At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator.<h4>Conclusion</h4>Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD.<h4>Trial registration</h4>ClinicalTrials.gov 01914965.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0173872&type=printable |
| spellingShingle | Harald Gelderblom Torsten Wüstenberg Tim McLean Lisanne Mütze Wilhelm Fischer Carsten Saft Rainer Hoffmann Sigurd Süssmuth Peter Schlattmann Erik van Duijn Bernhard Landwehrmeyer Josef Priller Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. PLoS ONE |
| title | Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. |
| title_full | Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. |
| title_fullStr | Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. |
| title_full_unstemmed | Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. |
| title_short | Bupropion for the treatment of apathy in Huntington's disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. |
| title_sort | bupropion for the treatment of apathy in huntington s disease a multicenter randomised double blind placebo controlled prospective crossover trial |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0173872&type=printable |
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