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NCT00555997 · ClinicalTrials.gov registry record · Phase 2
A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
A Phase 2 study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 7
- Study locations
NCT00555997: Completed Phase 2 study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
NCT00555997 is a Phase 2 study of Major Depressive Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 120 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (68% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00555997, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks. Hypothesis: There will be a statistically significant difference in the magnitude of response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be greater in the ziprasidone monotherapy group than in the placebo group.
Primary Outcome
Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ziprasidone
Study Locations (7)
Connecticut
- University of Connecticut Health Center - Farmington
- Comprehensive Psychiatric Care - Norwich
Massachusetts
- Massachusetts General Hosptial - Boston
- Cambridge Health Alliance - Cambridge
California
- Cedars-Sinai Medical Center - Los Angeles
Illinois
- Psychiatric Medicine Associates, L.L.C. - Chicago
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00555997 record still lists
NCT00555997 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00555997 lists 7 locations in 5 states (Connecticut, Massachusetts, California).
Frequently Asked Questions
What is clinical trial NCT00555997 about?
NCT00555997 is a clinical study titled "A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder". This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks. Hypothesis: There will be a statistically significant di...
What is the current status of trial NCT00555997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2008-03. Estimated completion is 2010-06.
What conditions does trial NCT00555997 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00555997?
The interventions under investigation include: Placebo (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT00555997?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00555997 being conducted?
This trial has 7 study locations across California, Connecticut, Illinois, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00555997's enrollment target sits among peer trials
120 117th of 282 higher than 160 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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