Pramipexole Versus Placebo in PD Patients With Depressive Symptoms
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00297778
First received: February 28, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopam ine 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 aff ect movement and include tremor, muscular rigidity, slowness in performing movements and loss of bal ance. 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 in volved in the experience of pleasure, and loss of pleasure in daily physical or social activity is o ne 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease Depression |
Drug: Pramipexole Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Secondary Outcome Measures:
- BDI-IA Clinical Response at Week 12 [ Time Frame: Week 12 ]BDI clinical response was defined as a reduction of ≥50% from baseline
- Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
- Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
- 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 ]The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
- Change From Baseline in the UPDRS Part II Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
- Change From Baseline in the UPDRS Part III Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
- Change From Baseline in the UPDRS Part II+III Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
- Clinical Global Impressions of Global Improvement (CGI-I) at Week 12 [ Time Frame: Week 12 ]The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)
- Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12 [ Time Frame: Baseline and Week 12 ]The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domian scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
- 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 ]The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
- 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 ]The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
| Enrollment: | 296 |
| Study Start Date: | March 2006 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: pramipexole |
Drug: Pramipexole
Dopamine agonist
|
| Placebo Comparator: placebo | Other: Placebo |
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 15-item Geriatric Depression Scale (GDS) > or = 5
- UPDRS Part I Score on Question #3 > or = 2
- Folsteins Mini-Mental State Examination (MMSE) score > 24
- Male or female patient with PD (UK PD Brain Bank criteria).
- Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
- Male or female patients aged 30 - 80 years.
- Ability to provide written informed consent.
- 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.
- Women of childbearing potential must be using an accepted contraceptive.
- Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
- History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
- Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- History of PD stereotactic brain surgery.
- Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
- History of active epilepsy within the past year.
- Current psychotherapy or behavior therapy while participating the trial
- Symptomatic orthostatic hypotension prior to randomization.
- Malignant melanoma or history of previously treated malignant melanoma.
- Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months.
- Patients who have received dopamine agonists within the past 30 days
- Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).
- Patients who are currently lactating.
- Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
- Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297778
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Show 77 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00297778 History of Changes |
| Other Study ID Numbers: | 248.596, Eudract 2005-003788-22 |
| Study First Received: | February 28, 2006 |
| Results First Received: | May 22, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Finland: Finnish Medicines Agency France: Afssaps Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg Italy: Comitato Etico Ospedale Civile S. Spirito, Università "G. D'Annunzio" Netherlands: Medish Etische toetsingscommissie Atrium MC Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Romania: National Medicines Agency, Bucharest Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow South Africa: Medicines Council Country Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios Sweden: Medical Products Agency Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Parkinson Disease Behavioral Symptoms Mood Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013