Sustaining Remission of Psychotic Depression (STOP-PD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Sustaining Remission of Psychotic Depression|
- Risk of relapse during the randomized phase. [ Time Frame: From entry into randomized phase until 36 weeks or earlier relapse ] [ Designated as safety issue: No ]
Relapse criteria include at least one of the following:
1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression (HAM-D)score of >17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a score of >2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
- Changes in metabolic measures [ Time Frame: From entry into randomized phase until up to 36 weeks later ] [ Designated as safety issue: Yes ]Weight and clinical laboratory analyses of cholesterol and triglycerides
- Age differences in treatment response Under60/60 or older [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Metabolic changes and symptom response will be compared for 'old' versus 'young'
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Olanzapine
Olanzapine 15mg/day plus sertraline 150mg/day. Fluctuations in dosing are allowed up to a maximum of olanzapine 20mg/day, sertraline 200mg/day.
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
Other Name: Zyprexa
Placebo Comparator: Placebo
Placebo will be used to taper the olanzapine over a period of four weeks and then substitute for the olanzapine for the remainder of the 36 week study.
Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427608
|United States, Massachusetts|
|Anthony Rothschild, MD||Recruiting|
|Worcester, Massachusetts, United States, 01605|
|Contact: Chelsea Kosma, MA 508-856-5312 Chelsea.Kosma@umassmed.edu|
|United States, New York|
|Barnett Meyers, MD||Recruiting|
|White Plains, New York, United States, 10605|
|Contact: Barbara Ladenheim, PhD 914-682-5472 email@example.com|
|Sub-Investigator: Vassilios Latoussakis, MD|
|Sub-Investigator: Patricia Marino, PhD|
|Sub-Investigator: Barbara Ladenheim, PhD|
|United States, Pennsylvania|
|Ellen Whyte, MD||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Joelle Kincman, PhD 412-246-6012 firstname.lastname@example.org|
|Alastair Flint, MD||Recruiting|
|Contact: Alastair Flint, MD 416-340-4788 email@example.com|
|Principal Investigator:||Barnett S Meyers, MD||Weill Medical College of Cornell University|
|Principal Investigator:||Alastair Flint, MD||University of Toronto|
|Principal Investigator:||Anthony Rothschild, MD||University of Massachusetts, Worcester|
|Principal Investigator:||Ellen Whyte, MD||University of Pittsburgh|