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NCT00086307 · ClinicalTrials.gov registry record · Phase 2
Lexapro and Pramipexole and to Treat Major Depression
A Phase 2 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT00086307 is a Phase 2 study of Major Depression that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 39 participants, below the 326-participant average among 28 other Major Depression trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00086307, a Phase 2 study of Major Depression, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study. Candidates must currently be in a major depressive episode of at least 4 weeks' duration, have failed to respond to treatment with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more than four antidepressants for the current episode. Candidates are screened with a physical examination, psychiatric evaluation, blood tests, review of vital signs, height and weight measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for women. Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment. They are then randomly assigned to take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks. During the study, participants come to the clinic eight times for health assessments and symptoms assessments, which include a check of vital signs and rating scales for depression and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected periodically to monitor health, detect pregnancy in women, and detect illicit drug use. At the end of the 6-week treatment period, participants have a physical examination, ECG, blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and plans are made for long-term treatment. Atendemos pacientes de habla hispana. ...
Conditions Studied
Interventions
- DRUG Escitalopram
- DRUG Pramipexole
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2004-06 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086307
The ClinicalTrials.gov registry entry for NCT00086307 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 326-participant average among 28 other Major Depression trials with a reported enrollment target (88% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depression appearing as the primary indexed condition, and to 2 interventions - of which Escitalopram is the first listed.
NCT00086307 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00086307 about?
NCT00086307 is a clinical study titled "Lexapro and Pramipexole and to Treat Major Depression". This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study...
What is the current status of trial NCT00086307?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2004-06. Estimated completion is 2010-03.
What conditions does trial NCT00086307 study?
This clinical trial studies the following conditions: Major Depression.
What interventions are being tested in trial NCT00086307?
The interventions under investigation include: Escitalopram (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT00086307?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00086307 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.