NCT00056472

Study of Pharmacotherapy of Psychotic Depression

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients. This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Conditions

• Major Depressive Disorder With Psychotic Features

Interventions

Type	Name	Description
DRUG	Olanzapine	10-20mg/day
DRUG	Sertraline	150-200mg/day
OTHER	placebo	tablet that ressembles sertraline but contains no medication

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2003-03-17
• Last updated: 2013-08-02
• Results posted: 2013-08-02

Locations

4 sites across 2 countries: United States, Canada