Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease; Depression
Intervention: Rotigotine; Placebo
Intervention description: Transdermal Patch
Content:
2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period
For advanced-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 8 week Maintenance period; Transdermal Patch
Size:
10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
Subjects randomized to placebo received matching placebo patches
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 380.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro; Depressive Symptom; Idiopathic Parkinson's disease

Summary:

      The purpose of this study was to show superiority of Rotigotine over placebo on improvement
      of depressive symptoms in subjects with idiopathic Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥ 20 years old

          -  Subjects diagnosed with idiopathic Parkinson's disease (according to the United
             Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's
             disease) at modified Hoehn and Yahr Scale stages I-III; do not have motor
             fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the
             Screening Visit as judged by the local investigator

          -  Subject has a Beck Depression Inventory II (BDI-II) score ≥ 16 as evidenced by
             depression rating scale study in Parkinson's disease (Schrag A et al, 2007)

          -  Subject has a Mini-Mental State Examination (MMSE) score ≥ 24

          -  If subject is taking Levodopa (L-DOPA) and derivatives, Monoamine Oxidase (MAO)
             B-inhibitors, anticholinergics agents, Catechol-O-Methyl Transferase (COMT) inhibitor
             or N-Methyl-D-Aspartate (NMDA) antagonist, he/she must have been on stable dose for at
             least 28 days prior to the Screening Visit

          -  If subject is taking an antidepressant drug such as selective serotonin reuptake
             inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion,
             tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least
             28 days prior to the Screening Visit and be maintained on that dose for the duration
             of the trial

        Exclusion Criteria:

          -  Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia,
             hallucinations or psychosis) that, in the opinion of the investigator, could
             jeopardize or would compromise the subject's ability to participate in this study

          -  Subject has a lifetime history of suicide attempt (including an active attempt,
             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
             months as indicated by a positive response ('Yes') to either Question 4 or Question 5
             of the C-SSRS at Screening (Visit 1)

          -  Current psychotherapy or behavior therapy while participating in this study

          -  Subject has received electroconvulsive therapy within 12 weeks of the Screening Visit

          -  Subject who has received dopamine agonists within 28 days of the Screening Visit

          -  Subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa,
             metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the
             Screening Visit