Sustaining Remission of Psychotic Depression (STOP-PD)
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|ClinicalTrials.gov Identifier: NCT01427608|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2011
Last Update Posted : November 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Depression||Drug: Olanzapine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sustaining Remission of Psychotic Depression|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
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.
- Risk of relapse during the randomized phase. [ Time Frame: From entry into randomized phase until 36 weeks or earlier relapse ]
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 ]Weight and clinical laboratory analyses of cholesterol and triglycerides
- Age differences in treatment response Under60/60 or older [ Time Frame: 36 weeks ]Metabolic changes and symptom response will be compared for 'old' versus 'young'
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427608
|United States, Massachusetts|
|Anthony Rothschild, MD|
|Worcester, Massachusetts, United States, 01605|
|United States, New York|
|George Alexopoulos, MD|
|White Plains, New York, United States, 10605|
|United States, Pennsylvania|
|Ellen Whyte, MD|
|Pittsburgh, Pennsylvania, United States, 15213|
|Alastair Flint, MD|
|Principal Investigator:||George Alexopoulos, 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|