CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 259 enrolled
Drug / intervention
Olanzapine +2 moredrug
Likely dose
Olanzapine 10-20 mg/day combined with sertraline 150-200 mg/dayAI-extracted
Key inclusion· 1
  • ✓Major depressive disorder, single or recurrent, with psychotic features
Key exclusion· 5
  • ✕History of substance abuse or dependence within 3 months prior to enrollment
  • ✕Acute or unstable medical illness
  • ✕Diagnosis of schizophrenia or other psychotic disorders
  • ✕Pregnant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00056472
NCT00056472Phase 3Completed
CompareCT.gov

Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

Weill Medical College of Cornell University·interventional·Posted Mar 17, 2003·Updated Aug 2, 2013

In Brief

A Phase 3 clinical trial evaluating Olanzapine, Sertraline, and 1 other intervention for Major Depressive Disorder With Psychotic Features. Completed, enrolled 259 participants across 4 sites in 2 countries.

Detailed Summary

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder With Psychotic Features
CountriesCanada, United States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2003
Enrollment StartJan 1, 2003
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 23.3 years ago

Interventions

Olanzapinedrug

10-20mg/day

Sertralinedrug

150-200mg/day

placeboother

tablet that ressembles sertraline but contains no medication