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NCT00000378 · ClinicalTrials.gov registry record · Phase 4
Antidepressant Treatment of Melancholia in Late Life
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT00000378: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00000378 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000378, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.
Primary Outcome
Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement
Interventions
- DRUG Sertraline
- DRUG Nortriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 1997-07 |
| Est. Completion | 2002-06 |
| Phase | Phase 4 |
What the finished NCT00000378 record still lists
NCT00000378 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT00000378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000378 about?
NCT00000378 is a clinical study titled "Antidepressant Treatment of Melancholia in Late Life". The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression...
What is the current status of trial NCT00000378?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 1997-07. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00000378?
The interventions under investigation include: Sertraline (DRUG), Nortriptyline (DRUG).
Who is sponsoring clinical trial NCT00000378?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000378's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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