At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years
- ✓Diagnosed with Major Depression (DSM-IV 296.33) without psychotic features, confirmed by SCID-P
- ✓Current major depressive episode of at least 4 weeks duration
- ✓MADRS score ≥20 at baseline visits
- ✕Psychotic features, schizophrenia, or bipolar disorder
- ✕History of drug or alcohol dependence/abuse (except nicotine or caffeine) within preceding 3 months
- ✕Prior inadequate response to escitalopram
- ✕Serious, unstable medical illness (hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combining a Dopamine Agonist and Selective Serotonin Reuptake Inhibitor for Treatment of Depression: A Double-Blind, Randomized Study
In Brief
A Phase 2 clinical trial evaluating Pramipexole and Escitalopram for Major Depression. Completed, enrolled 39 participants across 1 site.
Detailed 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. ...
Study Details
Timeline
Interventions
Pramipexole will be titrated so patients receive the following medication three times per day during the weeks noted: .125 milligrams (mg) in week 1, .250 mg in week 2, .5 mg in week 3, and .75 mg in weeks 4 to 6.
Escitalopram will be started at 10 mg/day and patients will continue on this throughout the study.