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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 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 110 participants.
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.
Interventions
- DRUG Sertraline
- DRUG Nortriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 1997-07 |
| Est. Completion | 2002-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000378
The ClinicalTrials.gov registry entry for NCT00000378 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sertraline is the first listed.
NCT00000378 reports 0 study locations.
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.
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