Status:
COMPLETED
Sustaining Remission of Psychotic Depression
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
University of Toronto
University of Massachusetts, Worcester
Conditions:
Psychotic Depression
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 d...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT01427608
Start Date
October 1 2011
End Date
November 30 2017
Last Update
March 5 2019
Active Locations (4)
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1
Anthony Rothschild, MD
Worcester, Massachusetts, United States, 01605
2
George Alexopoulos, MD
White Plains, New York, United States, 10605
3
Ellen Whyte, MD
Pittsburgh, Pennsylvania, United States, 15213
4
Alastair Flint, MD
Toronto, Canada