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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: Completed Phase 2 study of Major Depression, sponsored by National Institute of Mental Health (NIMH).
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. According to ClinicalTrials.gov, the official US trial registry.
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. ...
Primary Outcome
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.
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 |
What the finished NCT00086307 record still lists
NCT00086307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 326-participant average among 28 other Major Depression trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Major Depression
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 NCT00086307's enrollment target sits among peer trials
39 20th of 28 higher than 9 of 28 other Major Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depression 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.
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