Lexapro and Pramipexole and to Treat Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

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.

      ...
    

Detailed description: 
      Despite the availability of a wide range of antidepressant drugs, 30% to 40% of patients with
      major depression fail to respond to first-line antidepressant (e.g., selective serotonin
      reuptake inhibitors [SSRIs]) treatment, despite adequate dosage, duration, and compliance.
      Furthermore, these medications may take weeks to months to achieve their full effects, and in
      the meantime, patients continue to suffer from their symptoms and continue to be at risk of
      self-harm as well as harm to their personal and professional lives. Thus, there is a clear
      need to develop novel and improved therapeutics for treatment-resistant major depression that
      are more effective and have a rapid onset of action. Preclinical and clinical studies suggest
      that antidepressants with a combined mechanism of action (e.g., combination of a selective
      serotonin-reuptake inhibitor (SSRI) and a norepinephrine reuptake inhibitor) may be more
      effective than either agent alone in achieving remission (Nelson et al 2004). Thus, it stands
      to reason that other combinations of antidepressants with other mechanisms of action when
      combined may have a synergistic effect that is superior to an antidepressant with a single
      mechanism of action. Preclinical and clinical studies suggest that the dopaminergic system
      may play a major role in the pathophysiology of depression. Preclinical studies suggest
      synergistic antidepressant effects with the combination of a SSRI and a selective D3 receptor
      agonist in animal models of depression. Similarly, preliminary clinical studies suggest
      synergism with combination treatment that affects the serotonin and dopamine systems.
      Together, these data suggests that treatments which affect the serotonin and dopamine systems
      will be more effective than agents which use a single mechanism. We propose to compare the
      combination of a selective dopaminergic agonist and a SSRI in patients with
      treatment-resistant major depression. To our knowledge, this will be the only controlled
      double-blind study to date that will examine the efficacy of a serotonin and dopamine
      combination given from the start of treatment.

      Patients, ages 18 years or older, with a diagnosis of major depression (without psychotic
      features), will be randomized to the combination of a selective dopaminergic receptor agonist
      and a SSRI or either drug alone for a period of 6 weeks. Acute efficacy will be determined by
      demonstrating a greater remission rate using specified criteria. Approximately 115 patients
      with acute major depression will be enrolled in the study.
    

Intervention name(s): Pramipexole; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Pramipexole; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pramipexole; Escitalopran; Antidepressant; Dopaminergic Receptor Agonist; Depression; Major Depression