Sustaining Remission of Psychotic Depression

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.

Conditions

• Psychotic Depression

Interventions

DRUG

Sertraline + Olanzapine

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

DRUG

Sertraline + Placebo

Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• George Alexopoulos, MD · Weill Medical College of Cornell University

• Alastair Flint, MD · University of Toronto

• Anthony Rothschild, MD · University of Massachusetts, Worcester

• Ellen Whyte, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2017-11-30

Completion

2017-11-30

Countries

• United States
• Canada

Study Locations