Sustaining Remission of Psychotic Depression (STOP-PD)
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ClinicalTrials.gov Identifier: NCT01427608 |
Recruitment Status :
Completed
First Posted : September 1, 2011
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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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: Sertraline + Olanzapine Drug: Sertraline + Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 269 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Sustaining Remission of Psychotic Depression |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | November 30, 2017 |
Actual Study Completion Date : | November 30, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sertraline + Olanzapine
Randomized to continue with sertraline and olanzapine under double-blind conditions.
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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
Other Name: Zyprexa |
Placebo Comparator: Sertraline + Placebo
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions.
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Drug: Sertraline + Placebo
Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
Other Name: Placebo |
- Number of Subjects at Risk of Relapse During the Randomized Phase. [ Time Frame: From entry into randomized phase (baseline) and 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 Rating Scale 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 SADS (Schedule for Affective Disorders and Schizophrenia) 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: Weight [ Time Frame: From entry into randomized phase (baseline) and 36 weeks ]Change in weight from entry into randomized phase (baseline) and 36 weeks.
- Changes in Metabolic Measure: Cholesterol [ Time Frame: From entry into randomized phase (baseline) and 36 weeks ]Change in cholesterol from entry into randomized phase (baseline) and 36 weeks.
- Changes in Metabolic Measures: Triglycerides [ Time Frame: From entry into randomized phase (baseline) and 36 weeks ]Change in triglycerides from entry into randomized phase (baseline) and 36 weeks.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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 | |
Canada | |
Alastair Flint, MD | |
Toronto, Canada |
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 |
Documents provided by Weill Medical College of Cornell University:
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT01427608 |
Other Study ID Numbers: |
STOP-PD-II |
First Posted: | September 1, 2011 Key Record Dates |
Results First Posted: | March 5, 2019 |
Last Update Posted: | March 5, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 Sertraline 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 Antidepressive Agents |