CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 10 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00556140
NCT00556140Phase 3Completed
CompareCT.gov

The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability

Massachusetts General Hospital·interventional·Posted Nov 9, 2007·Updated Aug 20, 2012

In Brief

A Phase 3 clinical trial evaluating Aripiprazole for Psychotic Depression. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychotic Depression
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2007
Enrollment StartJun 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.6 years ago

Interventions

Aripiprazoledrug

Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study. Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.