Pramipexole Versus Placebo in PD Patients With Depressive Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00297778
• Date of registration: 28/02/2006
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: Pramipexole Versus Placebo in PD Patients With Depressive Symptoms
• Scientific 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
• Date of first enrolment: March 2006
• Target sample size: 296
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00297778
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Austria, Finland, France, Germany, Italy, Netherlands, Norway, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 15-item Geriatric Depression Scale (GDS) > or = 5

2. 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-HCG pregnancy test at
the Screening visit unless surgically sterile or last menstruation >or = 12 months
prior to signing IC.

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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Parkinson Disease

Intervention(s)

Drug: Pramipexole

Other: Placebo

Primary Outcome(s)

Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

BDI-IA Clinical Response at Week 12 [Time Frame: Week 12]

Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the UPDRS Part II Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the UPDRS Part II+III Total Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in the UPDRS Part III Total Score at Week 12 [Time Frame: Baseline and Week 12]

Clinical Global Impressions of Global Improvement (CGI-I) at Week 12 [Time Frame: Week 12]

Secondary ID(s)

248.596

Eudract 2005-003788-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors