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NCT00556140 · ClinicalTrials.gov registry record · Phase 3
The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression
A Phase 3 study of Psychotic Depression, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00556140: Completed Phase 3 study of Psychotic Depression, sponsored by Massachusetts General Hospital.
NCT00556140 is a Phase 3 study of Psychotic Depression that has completed, run by Massachusetts General Hospital. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00556140, a Phase 3 study of Psychotic Depression, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of \>23 considered severely depressed and \<7 to be mildly to not at all depressed.
Conditions Studied
Interventions
- DRUG Aripiprazole
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00556140 record still lists
NCT00556140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Psychotic Depression appearing as the primary indexed condition, and to 1 intervention - of which Aripiprazole is the first listed.
NCT00556140 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00556140 about?
NCT00556140 is a clinical study titled "The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression". 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.
What is the current status of trial NCT00556140?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2003-06. Estimated completion is 2008-01.
What conditions does trial NCT00556140 study?
This clinical trial studies the following conditions: Psychotic Depression.
What interventions are being tested in trial NCT00556140?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00556140?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00556140 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00556140's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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