Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Condition: Parkinson Disease; Depression
MeSH terms: Parkinson Disease; Depression
Intervention: Pramipexole; Placebo
Intervention description: Dopamine agonist
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the
      brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the
      brain (nerve cells) to control and harmonize muscle movements. Consequently, the main
      manifestations of the disease affect movement and include tremor, muscular rigidity, slowness
      in performing movements and loss of balance.

      However, the disease affects also other, non motor functions and may cause other disorders,
      such as depression. Depression may be a reaction to the disability caused by the disease, but
      many studies show that depression is more common in PD than in other chronic debilitating
      illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is
      also used in brain circuits involved in the experience of pleasure, and loss of pleasure in
      daily physical or social activity is one of the key manifestations of depression.

      The objective of the study is to assess whether pramipexole, at doses approved for the
      treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in
      PD patients.

      Also data on the safety of the product in the disease will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 15-item Geriatric Depression Scale (GDS) > or = 5

          2. Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2

          3. Folsteins Mini-Mental State Examination (MMSE) score > 24

          4. Male or female patient with PD (UK PD Brain Bank criteria).

          5. Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr
             Scale and optimally controlled PD symptoms .

          6. Male or female patients aged 30 - 80 years.

          7. Ability to provide written informed consent.

          8. Women of childbearing potential must have a negative serum
             beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless
             surgically sterile or last menstruation >or = 12 months prior to signing informed
             consent.

          9. Women of childbearing potential must be using an accepted contraceptive.

         10. Patients who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

        Exclusion Criteria:

          1. Previous history of allergic response, lack of efficacy or complications with
             pramipexole or its excipients.

          2. History of suicidal attempts in the last twelve months; presence of suicidal
             tendencies/potential.

          3. Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative
             diseases.

          4. History of PD stereotactic brain surgery.

          5. Surgery within 180 days of randomization that would negatively impact the patients
             participation in the study.

          6. History of active epilepsy within the past year.

          7. Current psychotherapy or behavior therapy while participating the trial

          8. Symptomatic orthostatic hypotension prior to randomization.

          9. Malignant melanoma or history of previously treated malignant melanoma.

         10. Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa,
             methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3
             months.

         11. Patients who have received dopamine agonists within the past 30 days

         12. Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).

         13. Patients who are currently lactating.

         14. Participation in other investigational drug studies or use of other investigational
             drugs within the previous 30 days prior to randomization.

         15. Any other laboratory assay abnormality, which could interfere with patient
             participation or interpretation of results, or could increase the risk for the patient

         16. Any other clinically significant medical/psychiatric condition, which could interfere
             with patient participation or interpretation of results, or could increase the risk
             for the patient