Sustaining Remission of Psychotic Depression

ClinicalTrials.gov ID: NCT01427608

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01427608
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Weill Medical College of Cornell University; Other
Enrollment: 269 participants

Conditions and interventions

Conditions

Psychotic Depression

Interventions

Sertraline + Olanzapine Drug
Sertraline + Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 85 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2011 (Type not available)
Primary completion: Nov 30, 2017 (Actual)
Completion: Nov 30, 2017 (Actual)
Last update posted: Mar 5, 2019

2011 – 2017

United States locations

U.S. sites: 3
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Anthony Rothschild, MD	Worcester	Massachusetts	01605	—
George Alexopoulos, MD	White Plains	New York	10605	—
Ellen Whyte, MD	Pittsburgh	Pennsylvania	15213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01427608, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 5, 2019 · Synced Nov 12, 2026