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Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial
| Content Provider | SAGE Publishing |
|---|---|
| Author | Thomas R.E. Barnes Leeson, Verity Paton, Carol Marston, Louise Osborn, David P. Kumar, Raj Keown, Patrick Zafar, Rameez Iqbal, Khalid Singh, Vineet Fridrich, Pavel Fitzgerald, Zachary Bagalkote, Hemant Haddad, Peter M. Husni, Mariwan Amos, Tim |
| Copyright Year | 2018 |
| Abstract | A second antipsychotic is commonly added to clozapine to treat refractory schizophrenia, notwithstanding the limited evidence to support such practice.Methods:The efficacy and adverse effects of this pharmacological strategy were examined in a double-blind, placebo-controlled, 12-week randomized trial of clozapine augmentation with amisulpride, involving 68 adults with treatment-resistant schizophrenia and persistent symptoms despite a predefined trial of clozapine.Results:There were no statistically significant differences between the amisulpride and placebo groups on the primary outcome measure (clinical response defined as a 20% reduction in total Positive and Negative Syndrome Scale score) or other mental state measures. However, the trial under recruited and was therefore underpowered to detect differences in the primary outcome, meaning that acceptance of the null hypothesis carries an increased risk of type II error. The findings suggested that amisulpride-treated participants were more likely to fulfil the clinical response criterion, odds ratio 1.17 (95% confidence interval 0.40–3.42) and have a greater reduction in negative symptoms, but these numerical differences were not statistically significant and only evident at 12 weeks. A significantly higher proportion of participants in the amisulpride group had at least one adverse event compared with the control group (p = 0.014), and these were more likely to be cardiac symptoms.Conclusions:Treatment for more than 6 weeks may be required for an adequate trial of clozapine augmentation with amisulpride. The greater side-effect burden associated with this treatment strategy highlights the need for safety and tolerability monitoring, including vigilance for indicators of cardiac abnormalities, when it is used in either a clinical or research setting. |
| Related Links | https://journals.sagepub.com/doi/pdf/10.1177/2045125318762365?download=true |
| Starting Page | 185 |
| Ending Page | 197 |
| Page Count | 13 |
| ISSN | 20451253 |
| Issue Number | 7 |
| Volume Number | 8 |
| Journal | Therapeutic Advances in Psychopharmacology (TPP) |
| e-ISSN | 20451261 |
| DOI | 10.1177/2045125318762365 |
| Language | English |
| Publisher | Sage Publications UK |
| Publisher Date | 2018-03-08 |
| Publisher Place | London |
| Access Restriction | Open |
| Rights Holder | © The Author(s), 2018 |
| Subject Keyword | amisulpride clozapine augmentation treatment-resistant schizophrenia antipsychotic medication clozapine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology (medical) Psychiatry and Mental Health |
