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dc.contributor.authorBrown, Hannah E.
dc.contributor.authorFreudenreich, Oliver
dc.contributor.authorFan, Xiaoduo
dc.contributor.authorHeard, Stephen O.
dc.contributor.authorGoff, Donald
dc.contributor.authorPetrides, George
dc.contributor.authorHarrington, Amy
dc.contributor.authorKane, John M.
dc.contributor.authorJudge, Heidi
dc.contributor.authorHoeppner, Bettina
dc.contributor.authorFava, Maurizio
dc.contributor.authorPerlis, Roy H.
dc.date2022-08-11T08:10:31.000
dc.date.accessioned2022-08-23T17:11:38Z
dc.date.available2022-08-23T17:11:38Z
dc.date.issued2019-07-01
dc.date.submitted2019-08-29
dc.identifier.citation<p>JAMA Psychiatry. 2019 Jul 1;76(7):691-699. doi: 10.1001/jamapsychiatry.2019.0151. <a href="https://doi.org/10.1001/jamapsychiatry.2019.0151">Link to article on publisher's site</a></p>
dc.identifier.issn2168-622X (Linking)
dc.identifier.doi10.1001/jamapsychiatry.2019.0151
dc.identifier.pmid30916714
dc.identifier.urihttp://hdl.handle.net/20.500.14038/46322
dc.description.abstractImportance: Antipsychotic medications for the treatment of schizophrenia have limitations, and new treatments are needed. A prior pilot investigation suggested that adjunctive sodium nitroprusside (SNP) administered intravenously had rapid efficacy in the treatment of patients with schizophrenia. Objective: To determine the efficacy and tolerability of intravenous SNP infused at a rate of 0.5 mug/kg/min for 4 hours in patients with schizophrenia with some degree of treatment resistance. Design, Setting, and Participants: Multicenter, randomized, double-blind acute treatment study using a sequential parallel comparison design conducted in two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017. Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year. A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses. A modified intent-to-treat analysis was used. Interventions: Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences: SNP and SNP, placebo and SNP, and placebo and placebo. The SNP and SNP group received SNP in phase 1 and SNP in phase 2 for the purpose of blinding, but the data from phase 2 were not included in the results. The placebo and SNP group received placebo in phase 1 and SNP in phase 2. If there was no response to placebo in phase 1, data from phase 2 were included in the analyses. The placebo and placebo group received placebo in both phases; if there was no response to placebo in phase 1, data from phase 2 were included in the analyses. Main Outcomes and Measures: Effectiveness of SNP compared with placebo in improving Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores across each 2-week phase. Results: Fifty-two participants (12 women and 40 men) were included in the study. In the SNP and SNP group, the mean (SD) age was 47.1 (10.5) years. In the placebo and SNP group, the mean (SD) age was 45.9 (12.3) years. In the placebo and placebo group, the mean (SD) age was 40.4 (11.0) years. There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted beta = -1.04; z = -0.59; P = .57), PANSS-positive (weighted beta = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted beta = -0.12; z = -0.19; P = .85) scores. No significant differences in safety or tolerability measures were identified. Conclusions and Relevance: Although intravenous SNP is well tolerated, it was not an efficacious adjunctive treatment of positive or negative symptoms of psychosis among outpatients with schizophrenia with prior history of treatment resistance. Trial Registration: ClinicalTrials.gov identifier: NCT02164981.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=30916714&dopt=Abstract">Link to Article in PubMed</a></p>
dc.relation.urlhttps://doi.org/10.1001/jamapsychiatry.2019.0151
dc.rights© 2019 American Medical Association. Publisher PDF posted after 12 months as allowed by the publisher's author rights policy at https://jamanetwork.com/journals/jamapsychiatry/pages/instructions-for-authors#SecDepositingResearchArticlesinApprovedPublicRepositories
dc.subjectschizophrenia
dc.subjectantipsychotic medications
dc.subjectadjunctive sodium nitroprusside
dc.subjecttherapy
dc.subjectAnesthesia and Analgesia
dc.subjectMental and Social Health
dc.subjectMental Disorders
dc.subjectPsychiatry
dc.titleEfficacy and Tolerability of Adjunctive Intravenous Sodium Nitroprusside Treatment for Outpatients With Schizophrenia: A Randomized Clinical Trial
dc.typeArticle
dc.source.journaltitleJAMA psychiatry
dc.source.volume76
dc.source.issue7
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1883&amp;context=psych_pp&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/psych_pp/876
dc.legacy.embargo2020-07-01T00:00:00-07:00
dc.identifier.contextkey15233896
refterms.dateFOA2022-08-23T17:11:38Z
html.description.abstract<p>Importance: Antipsychotic medications for the treatment of schizophrenia have limitations, and new treatments are needed. A prior pilot investigation suggested that adjunctive sodium nitroprusside (SNP) administered intravenously had rapid efficacy in the treatment of patients with schizophrenia.</p> <p>Objective: To determine the efficacy and tolerability of intravenous SNP infused at a rate of 0.5 mug/kg/min for 4 hours in patients with schizophrenia with some degree of treatment resistance.</p> <p>Design, Setting, and Participants: Multicenter, randomized, double-blind acute treatment study using a sequential parallel comparison design conducted in two 2-week phases at 4 academic medical centers beginning May 20, 2015, and ending March 31, 2017. Participants were adults 18 to 65 years of age with a diagnosis of schizophrenia as confirmed by the Structured Clinical Interview for DSM-IV, taking antipsychotic medication for at least 8 weeks, and had at least 1 failed trial of an antipsychotic medication within the past year. A total of 90 participants consented, 60 participants enrolled, and 52 participants were included in the analyses. A modified intent-to-treat analysis was used.</p> <p>Interventions: Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences: SNP and SNP, placebo and SNP, and placebo and placebo. The SNP and SNP group received SNP in phase 1 and SNP in phase 2 for the purpose of blinding, but the data from phase 2 were not included in the results. The placebo and SNP group received placebo in phase 1 and SNP in phase 2. If there was no response to placebo in phase 1, data from phase 2 were included in the analyses. The placebo and placebo group received placebo in both phases; if there was no response to placebo in phase 1, data from phase 2 were included in the analyses.</p> <p>Main Outcomes and Measures: Effectiveness of SNP compared with placebo in improving Positive and Negative Syndrome Scale (PANSS) total, positive, and negative scores across each 2-week phase.</p> <p>Results: Fifty-two participants (12 women and 40 men) were included in the study. In the SNP and SNP group, the mean (SD) age was 47.1 (10.5) years. In the placebo and SNP group, the mean (SD) age was 45.9 (12.3) years. In the placebo and placebo group, the mean (SD) age was 40.4 (11.0) years. There were no significant differences between the SNP and placebo groups at baseline or in change from baseline for PANSS-total (weighted beta = -1.04; z = -0.59; P = .57), PANSS-positive (weighted beta = -0.62; z = -0.93; P = .35), or PANSS-negative (weighted beta = -0.12; z = -0.19; P = .85) scores. No significant differences in safety or tolerability measures were identified.</p> <p>Conclusions and Relevance: Although intravenous SNP is well tolerated, it was not an efficacious adjunctive treatment of positive or negative symptoms of psychosis among outpatients with schizophrenia with prior history of treatment resistance.</p> <p>Trial Registration: ClinicalTrials.gov identifier: NCT02164981.</p>
dc.identifier.submissionpathpsych_pp/876
dc.contributor.departmentDepartment of Anesthesiology and Perioperative Medicine
dc.contributor.departmentImplementation Science and Practice Advances Research Center
dc.contributor.departmentDepartment of Psychiatry
dc.source.pages691-699


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