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dc.contributor.authorFlint, Alastair J.
dc.contributor.authorMeyers, Barnett S.
dc.contributor.authorRothschild, Anthony J.
dc.contributor.authorWhyte, Ellen M.
dc.contributor.authorMulsant, Benoit H.
dc.contributor.authorRudorfer, Matthew V.
dc.contributor.authorMarino, Patricia
dc.contributor.authorSTOP-PD II Study Group
dc.date2022-08-11T08:10:28.000
dc.date.accessioned2022-08-23T17:10:37Z
dc.date.available2022-08-23T17:10:37Z
dc.date.issued2013-01-25
dc.date.submitted2013-03-28
dc.identifier.citationBMC Psychiatry. 2013 Jan 25;13:38. doi: 10.1186/1471-244X-13-38. <a href="http://dx.doi.org/10.1186/1471-244X-13-38" target="_blank">Link to article on publisher's site</a>
dc.identifier.issn1471-244X (Linking)
dc.identifier.doi10.1186/1471-244X-13-38
dc.identifier.pmid23351522
dc.identifier.urihttp://hdl.handle.net/20.500.14038/46087
dc.description.abstractBACKGROUND: Psychotic depression (PD) is a severe disabling disorder with considerable morbidity and mortality. Electroconvulsive therapy and pharmacotherapy are each efficacious in the treatment of PD. Expert guidelines recommend the combination of antidepressant and antipsychotic medications in the acute pharmacologic treatment of PD. However, little is known about the continuation treatment of PD. Of particular concern, it is not known whether antipsychotic medication needs to be continued once an episode of PD responds to pharmacotherapy. This issue has profound clinical importance. On the one hand, the unnecessary continuation of antipsychotic medication exposes a patient to adverse effects, such as weight gain and metabolic disturbance. On the other hand, premature discontinuation of antipsychotic medication has the potential risk of early relapse of a severe disorder. METHODS/DESIGN: The primary goal of this multicenter randomized placebo-controlled trial is to assess the risks and benefits of continuing antipsychotic medication in persons with PD once the episode of depression has responded to treatment with an antidepressant and an antipsychotic. Secondary goals are to examine age and genetic polymorphisms as predictors or moderators of treatment variability, potentially leading to more personalized treatment of PD. Individuals aged 18-85 years with unipolar psychotic depression receive up to 12 weeks of open-label treatment with sertraline and olanzapine. Participants who achieve remission of psychosis and remission/near-remission of depressive symptoms continue with 8 weeks of open-label treatment to ensure stability of remission. Participants with stability of remission are then randomized to 36 weeks of double-blind treatment with either sertraline and olanzapine or sertraline and placebo. Relapse is the primary outcome. Metabolic changes are a secondary outcome. DISCUSSION: This trial will provide clinicians with much-needed evidence to guide the continuation and maintenance treatment of one of the most disabling and lethal of psychiatric disorders. TRIAL REGISTRATION AND URL: NCT: NCT01427608.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=23351522&dopt=Abstract">Link to Article in PubMed</a>
dc.rights© 2013 Flint et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.subjectAffective Disorders, Psychotic
dc.subjectDepressive Disorder, Major
dc.subjectBehavioral Disciplines and Activities
dc.subjectMental and Social Health
dc.subjectPsychiatry
dc.subjectPsychiatry and Psychology
dc.titleSustaining remission of psychotic depression: rationale, design and methodology of STOP-PD II
dc.typeJournal Article
dc.source.journaltitleBMC psychiatry
dc.source.volume13
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1625&amp;context=psych_pp&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/psych_pp/625
dc.identifier.contextkey3968644
refterms.dateFOA2022-08-23T17:10:37Z
html.description.abstract<p>BACKGROUND: Psychotic depression (PD) is a severe disabling disorder with considerable morbidity and mortality. Electroconvulsive therapy and pharmacotherapy are each efficacious in the treatment of PD. Expert guidelines recommend the combination of antidepressant and antipsychotic medications in the acute pharmacologic treatment of PD. However, little is known about the continuation treatment of PD. Of particular concern, it is not known whether antipsychotic medication needs to be continued once an episode of PD responds to pharmacotherapy. This issue has profound clinical importance. On the one hand, the unnecessary continuation of antipsychotic medication exposes a patient to adverse effects, such as weight gain and metabolic disturbance. On the other hand, premature discontinuation of antipsychotic medication has the potential risk of early relapse of a severe disorder.</p> <p>METHODS/DESIGN: The primary goal of this multicenter randomized placebo-controlled trial is to assess the risks and benefits of continuing antipsychotic medication in persons with PD once the episode of depression has responded to treatment with an antidepressant and an antipsychotic. Secondary goals are to examine age and genetic polymorphisms as predictors or moderators of treatment variability, potentially leading to more personalized treatment of PD. Individuals aged 18-85 years with unipolar psychotic depression receive up to 12 weeks of open-label treatment with sertraline and olanzapine. Participants who achieve remission of psychosis and remission/near-remission of depressive symptoms continue with 8 weeks of open-label treatment to ensure stability of remission. Participants with stability of remission are then randomized to 36 weeks of double-blind treatment with either sertraline and olanzapine or sertraline and placebo. Relapse is the primary outcome. Metabolic changes are a secondary outcome.</p> <p>DISCUSSION: This trial will provide clinicians with much-needed evidence to guide the continuation and maintenance treatment of one of the most disabling and lethal of psychiatric disorders.</p> <p>TRIAL REGISTRATION AND URL: NCT: NCT01427608.</p>
dc.identifier.submissionpathpsych_pp/625
dc.contributor.departmentDepartment of Psychiatry
dc.source.pages38


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