Sustaining Remission of Psychotic Depression
Condition: Psychotic Depression
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The acute phase of this study will monitor the response to a combination of an atypical
      antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute
      treatment of the disorder. It is predicted that this combination will improve symptoms of
      psychotic depression and be associated metabolic side effects. Factors that moderate
      tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks,
      followed by a period of 8 weeks during which participants will continue to take the same
      medications to stabilize the remission from symptoms of psychotic depression.

      The maintenance phase will be a randomized, double-blind, placebo-controlled study of
      olanzapine for a period of up to 36 weeks to test whether continuing this combination
      decreases the risk of relapse and whether discontinuing the combination leads to improvement
      in metabolic measures. Subjects who complete the acute phase will be asked to consent
      separately to the randomized maintenance phase.
    

Detailed description: 
      The original STOP-PD study established that the combination of olanzapine and sertraline was
      significantly better than olanzapine alone in achieving remission of psychotic depression.
      This STOP-PD-II Sustaining Remission study aims to assess the long-term tolerability of
      taking this combination of medications and their efficacy at preventing a relapse of the
      symptoms. The acute phase of the study will monitor the efficacy and tolerability of the
      olanzapine and sertraline combination, including investigation of weight and metabolic
      variables, age effects on treatment response and tolerability, and the association of genetic
      polymorphisms to response or relapse. When subjects are stabilized on these medications for a
      period of 8 weeks they will be invited to participate in the randomized phase of the
      research: the olanzapine will be placebo-controlled, meaning half of the subjects will
      continue to take the olanzapine/sertraline combination and half will take a
      sertraline/placebo combination, for a period of 36 weeks. Symptoms and side effects will be
      monitored regularly throughout this phase. Randomization will be stratified on a 1:1 basis by
      age 60 and above.
    

Intervention name(s): Sertraline + Olanzapine; Sertraline + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening; Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
Other intervention name(s): Zyprexa; Placebo
Intervention MeSH terms: Olanzapine; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment