Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ
<p>Abstract</p> <p>Background</p> <p>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 combinatio...
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| Format: | Article |
| Language: | English |
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BMC
2013-01-01
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| Series: | BMC Psychiatry |
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| Online Access: | http://www.biomedcentral.com/1471-244X/13/38 |
| _version_ | 1811296708553867264 |
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| author | Flint Alastair J Meyers Barnett S Rothschild Anthony J Whyte Ellen M Mulsant Benoit H Rudorfer Matthew V Marino Patricia |
| author_facet | Flint Alastair J Meyers Barnett S Rothschild Anthony J Whyte Ellen M Mulsant Benoit H Rudorfer Matthew V Marino Patricia |
| author_sort | Flint Alastair J |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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</p> <p>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</p> <p>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</p> <p>NCT: <a href="http://wwwclinicaltrials.gov/NCT01427608">NCT01427608</a></p> |
| first_indexed | 2024-04-13T05:52:28Z |
| format | Article |
| id | doaj.art-aea43c06d5a742f8883a23675037cf24 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-04-13T05:52:28Z |
| publishDate | 2013-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-aea43c06d5a742f8883a23675037cf242022-12-22T02:59:43ZengBMCBMC Psychiatry1471-244X2013-01-011313810.1186/1471-244X-13-38Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙFlint Alastair JMeyers Barnett SRothschild Anthony JWhyte Ellen MMulsant Benoit HRudorfer Matthew VMarino Patricia<p>Abstract</p> <p>Background</p> <p>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</p> <p>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</p> <p>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</p> <p>NCT: <a href="http://wwwclinicaltrials.gov/NCT01427608">NCT01427608</a></p>http://www.biomedcentral.com/1471-244X/13/38Major depressive disorder with psychotic featuresPsychotic depressionRandomized controlled trialAntipsychotic discontinuationRelapseMetabolic effectsAgedMulti-center study |
| spellingShingle | Flint Alastair J Meyers Barnett S Rothschild Anthony J Whyte Ellen M Mulsant Benoit H Rudorfer Matthew V Marino Patricia Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ BMC Psychiatry Major depressive disorder with psychotic features Psychotic depression Randomized controlled trial Antipsychotic discontinuation Relapse Metabolic effects Aged Multi-center study |
| title | Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ |
| title_full | Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ |
| title_fullStr | Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ |
| title_full_unstemmed | Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ |
| title_short | Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ |
| title_sort | sustaining remission of psychotic depression rationale design and methodology of stop pd ιι |
| topic | Major depressive disorder with psychotic features Psychotic depression Randomized controlled trial Antipsychotic discontinuation Relapse Metabolic effects Aged Multi-center study |
| url | http://www.biomedcentral.com/1471-244X/13/38 |
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