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Open Access Study protocol

Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD ΙΙ

Alastair J Flint1239*, Barnett S Meyers4, Anthony J Rothschild5, Ellen M Whyte6, Benoit H Mulsant17, Matthew V Rudorfer8, Patricia Marino4 and on behalf of the STOP-PD II Study Group

Author affiliations

1 Department of Psychiatry, University of Toronto, Toronto, Canada

2 Department of Psychiatry, University Health Network, Toronto, Canada

3 Toronto General and Toronto Rehab Research Institutes, Toronto, Canada

4 Department of Psychiatry Weill Medical College of Cornell University and New York Presbyterian Hospital–Westchester Division, New York, USA

5 University of Massachusetts Medical School and UMass Memorial Health Care, Worcester, USA

6 Western Psychiatric Institute and Clinic, Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, USA

7 Centre for Addiction and Mental Health, Toronto, Canada

8 National Institute of Mental Health, Bethesda, USA

9 Toronto General Hospital, 200 Elizabeth St., 8 Eaton North–Room 238, Toronto, Ontario, M5G 2C4, Canada

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Citation and License

BMC Psychiatry 2013, 13:38  doi:10.1186/1471-244X-13-38

Published: 25 January 2013

Abstract

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.

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

Keywords:
Major depressive disorder with psychotic features; Psychotic depression; Randomized controlled trial; Antipsychotic discontinuation; Relapse; Metabolic effects; Aged; Multi-center study