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

Abstract

BackgroundPsychotic 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/designThe 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.DiscussionThis 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 URLNCT: NCT01427608

Persistent delusional theme over 13 episodes of psychotic depression

“…This is consistent with the literature (21-23). An ongoing study may provide important new knowledge regarding an effective relapse preventing pharmacological regimen for PD (24). …”

Resting state functional connectivity in patients with remitted psychotic depression: A multi-centre STOP-PD study

“…The design of STOP-PD II, including eligibility criteria, has been described in detail [ 18 ]. Briefly, STOP-PD II participants were aged 18–85 years and met diagnostic criteria for non-bipolar MDD with psychotic features based on the Structured Clinical Interview for DSM-IV-TR Axis I Disorders administered by a trained research associate.…”

Challenges in the Treatment of Major Depressive Disorder With Psychotic Features

“…On the other hand, the unnecessary continuation of antipsychotic medication exposes a patient to potential adverse effects. An NIMH study to address the question as to how long a patient with psychotic depression who is in remission needs to stay on the antipsychotic medication is currently underway 93 at Weill Medical College of Cornell University, the University of Pittsburgh School of Medicine, the University of Massachusetts Medical School, and the University of Toronto Department of Psychiatry (NCT01427608).…”