Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms
Brief 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.


Options:
A: 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
B: Inclusion criteria patients:

* Idiopathic Parkinson's Disease
* Indication for referral to occupational therapy
* Home dwelling

Inclusion criteria caregivers

* Available for informal support minimal two times a week to a patient who participates in the study
* Available to take part in the intervention

Exclusion Criteria:

* Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score \< 24).
* Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
* Current participation in other allied health research (i.e. PARKFIT)
* Having received occupational therapy intervention in the last 3 months
C: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.
D: Inclusion Criteria:

* Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
* Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
* Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
* Willing and able to give informed consent.

Exclusion Criteria:

* Subjects younger than 30 or older than 80 years.
* Subjects with loss of postural reflexes.
* Subjects with UPDRS Tremor score of 3 or greater in any limb.
* Subjects with Hoehn \&Yahr Stage III or greater at screening.
* Subjects with freezing while walking.
* Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism:
* History of repeated strokes with stepwise progression of Parkinsonian features
* History of repeated head injury or history of definite encephalitis
* Sustained remission
* Supranuclear gaze palsy
* Cerebellar signs
* Early severe autonomic involvement
* Babinski's sign
* Presence of a cerebral tumour or communicating hydrocephalus
* MPTP exposure
* Oculogyric crises
* Subjects who have had previous use of rasagiline or selegiline
* Subjects having used other anti-PD medication basis at any time prior to baseline
* Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test)
* Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study.
* Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation
* Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline
* Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy
* Subjects with significant cognitive impairment as defined by MMSE score \< 26
* Subjects with clinically significant psychiatric illness, including major depression \[Beck Depression Inventory (short form) ≥15
* Subjects with a history of alcohol or substance abuse within the past 2 years
* Subjects who have taken any experimental medications within 60 days prior to baseline
* Subjects who have used coenzyme Q10 (in daily doses \> 300 mg) within 120 days prior to baseline
* Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline
* Subjects who have used antidepressants within 42 days prior to baseline
* Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline
* Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline
* Women who are not postmenopausal, surgically sterilized, or using adequate birth control \[oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient\]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women

Answer: A