Sustaining Remission of Psychotic Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Psychotic Depression

In brief

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.

Key facts

Study ID: NCT01427608
Run by: Weill Medical College of Cornell University
People needed: 269
Starts: 2011-10-01
Expected to finish: 2017-11-30
Last updated by the study team: 2019-03-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Anthony Rothschild, MD — Worcester, Massachusetts, United States
George Alexopoulos, MD — White Plains, New York, United States
Ellen Whyte, MD — Pittsburgh, Pennsylvania, United States
Alastair Flint, MD — Toronto, Canada

Full record on ClinicalTrials.gov

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