Lexapro and Pramipexole and to Treat Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Pramipexole; Escitalopram
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pramipexole; Escitalopran; Antidepressant; Dopaminergic Receptor Agonist; Depression; Major Depression

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.

      ...
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Male or female subjects, 18 to 65 years of age.

          2. Female subjects of childbearing potential must be using a medically accepted means of
             contraception.

          3. Each subject must have a level of understanding sufficient to agree to all required
             tests and examinations and sign an informed consent document.

          4. Subjects must fulfill DSM-IV criteria for Major Depression (296.33) without psychotic
             features, based on clinical assessment and confirmed by a structured diagnostic
             interview, SCID-P.

          5. Subjects must have an initial score of greater than or equal to 20 on the MADRS at
             Visit 1 and Visit 2.

          6. Subjects must not have a greater than a 25% decrease in the MADRS total scores during
             washout (between Visits 1 and 2).

          7. Current or past history of lack of response to at least one adequate antidepressant
             trial (SSRI) operationally defined using the Antidepressant Treatment History Form
             (ATHF) (Sackeim 2001b). If this criteria has not been met, a four-week prospective
             trial of a standard antidepressant (at the patients' and clinicians' discretion) may
             be given. Subjects are excluded if greater than four failed antidepressant trials for
             the current major depressive (adequate dose and duration as defined by the ATHF).

          8. Current major depressive episode of at least 4 weeks duration.

             EXCLUSION CRITERIA:

          9. Presence of psychotic features or a diagnosis of Schizophrenia or any other psychotic
             disorder or bipolar disorder as defined in the DSM-IV.

         10. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for
             nicotine or caffeine) within the preceding 3 months.

         11. Previously failed to respond to an adequate trial (dose and duration) of escitalopram.

         12. Female subjects who are either pregnant or nursing.

         13. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory,
             cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
             immunologic, or hematologic disease.

         14. Subjects with uncorrected hypothyroidism or hyperthyroidism.

         15. Subjects with one or more seizures without a clear and resolved etiology.

         16. Previous treatment with pramipexole.

         17. Treatment with a reversible MAOI within 2 weeks prior to Visit 2.

         18. Treatment with fluoxetine within 5 weeks prior to Visit 2.

         19. Treatment with any other concomitant medication not allowed (Appendix A) 7 days prior
             to study Visit 2.

         20. Treatment with clozapine or ECT within 3 months prior to study Visit 2.

         21. Judged clinically to be an acute suicidal risk.

         22. Psychotherapy will not be permitted during the study.