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NCT00056472 · ClinicalTrials.gov registry record · Phase 3
Study of Pharmacotherapy of Psychotic Depression
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 3
- Development phase
- 259
- Enrollment target
NCT00056472: Completed Phase 3 study, sponsored by Weill Medical College of Cornell University.
NCT00056472 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 259 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056472, a Phase 3 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 259 participants
- Enrollment target
Study Summary
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
Primary Outcome
Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior.
Interventions
- OTHER placebo
- DRUG Olanzapine
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2003-01 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00056472 record still lists
NCT00056472 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00056472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00056472 about?
NCT00056472 is a clinical study titled "Study of Pharmacotherapy of Psychotic Depression". This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
What is the current status of trial NCT00056472?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2003-01. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00056472?
The interventions under investigation include: placebo (OTHER), Olanzapine (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT00056472?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00056472's enrollment target sits among peer trials
259 1234th of 2000 higher than 766 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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