Sustaining Remission of Psychotic Depression (STOP-PD)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2017 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
Collaborators:
University of Toronto
University of Massachusetts, Worcester
University of Pittsburgh
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01427608
First received: August 30, 2011
Last updated: January 10, 2017
Last verified: January 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Psychotic Depression |
Drug: Olanzapine Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sustaining Remission of Psychotic Depression |
Resource links provided by NLM:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
Other Outcome Measures:
- 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'
| Estimated Enrollment: | 392 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: 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
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.
|
Drug: Placebo
Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged 18-85 years, inclusive
- Diagnosis: Diagnostic Statistical Manual-IV Trade Revision (DSM IV-TR) non-bipolar major depression with psychotic features established by both clinical interview with research psychiatrist and administration of SCID-IV.
- Score >2 on Schedule for Affective Disorders (SADS) delusion severity item
- Score >1 on any of the three conviction items of the Delusion Assessment Scale (DAS) (does not alter belief in response to reality testing)
- 17-item HAM-D score of >20
Exclusion Criteria:
- Current or lifetime DSM-IV-TR history of schizophrenia or other psychotic disorders or meeting current criteria for brief psychotic disorder, body dysmorphic disorder or obsessive-compulsive disorder
- Current or lifetime DSM-IV-TR bipolar affective disorder
- History of DSM-IV-TR defined alcohol or substance abuse or dependence within the past three months
- Dementia or clinically significant cognitive impairment prior to index episode of depression, and/or a mean score >3 on 26-item caregiver assessment
- Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset before age 35, and/or diabetes mellitus complicated by prior documented episode of ketoacidosis
- Acute or unstable medical illness within the past 3 months; current abnormal serum free T4; current abnormally low vitamin B4 or folic acid level; medical conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation; neurological disease associated with extrapyramidal signs and symptoms; epilepsy, if the person has had one or more grand mal seizures within the past 12 months.
- The need for treatment with any psychotropic medication other than sertraline, olanzapine or lorazepam; or with an anticonvulsant medication with mood-stabilizing properties.
- Current pregnancy or plan to become pregnant during the course of the study; breast feeding in women with infants.
- A documented history of being unable to tolerate olanzapine or sertraline including significant bradycardia (heart rate of <50 bpm), and serum sodium level of 129mmol/L or below.
- History of non-response of the index episode of psychotic depression to at least a 6-week trial of at least 150mg/day sertraline combined with 15mg/day olanzapine
- Patients showing ongoing improvement in current episode of psychotic depression with treatment other than sertraline or olanzapine
- Patients who are in immediate need of electroconvulsive therapy (ECT) (imminent risk of suicide, refusing to eat, catatonic)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427608
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427608
Locations
| 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 | |
| George Alexopoulos, MD | Recruiting |
| White Plains, New York, United States, 10605 | |
| Contact: Patricia Marino, PhD 914-997-8691 pam2029@med.cornell.edu | |
| Sub-Investigator: Vassilios Latoussakis, MD | |
| Sub-Investigator: Patricia Marino, PhD | |
| Sub-Investigator: Barnett Meyers, MD | |
| United States, Pennsylvania | |
| Ellen Whyte, MD | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Joelle Kincman, PhD 412-246-6012 scanjm2@upmc.edu | |
| Canada | |
| Alastair Flint, MD | Recruiting |
| Toronto, Canada | |
| Contact: Alastair Flint, MD 416-340-4788 alastair.flint@uhn.on.ca | |
Sponsors and Collaborators
Weill Medical College of Cornell University
University of Toronto
University of Massachusetts, Worcester
University of Pittsburgh
Investigators
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01427608 History of Changes |
| Other Study ID Numbers: |
STOP-PD-II |
| Study First Received: | August 30, 2011 |
| Last Updated: | January 10, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Mental Disorders Psychotic Disorders Bipolar Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Olanzapine Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |
ClinicalTrials.gov processed this record on May 24, 2017