Lexapro and Pramipexole and to Treat Major Depression
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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.
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