Clinical trial NCT01523301: Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Official title: Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro
Depressive Symptom
Idiopathic Parkinson's disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 380
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage Parkinson's disease and 30-day Safety Follow-Up Period.

The maximum study durations for an individual subject with early-stage Parkinson's disease and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.

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

Primary outcomes:
measure: Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Secondary outcomes:
measure: Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
measure: Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
measure: Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
measure: Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
measure: Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
measure: Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: 03
city: Anyang
country: Korea, Republic of
facility: 19
city: Busan
country: Korea, Republic of
facility: 08
city: Busan
country: Korea, Republic of
facility: 26
city: Chungbuk
country: Korea, Republic of
facility: 23
city: Daegu
country: Korea, Republic of
facility: 04
city: Daegu
country: Korea, Republic of
facility: 05
city: Daejon
country: Korea, Republic of
facility: 16
city: Goyang
country: Korea, Republic of
facility: 28
city: Gwangju
country: Korea, Republic of
facility: 24
city: Gwangju
country: Korea, Republic of
facility: 29
city: Gyeonggi-Do
country: Korea, Republic of
facility: 11
city: Jinju
country: Korea, Republic of
facility: 15
city: Seoul
country: Korea, Republic of
facility: 01
city: Seoul
country: Korea, Republic of
facility: 02
city: Seoul
country: Korea, Republic of
facility: 06
city: Seoul
country: Korea, Republic of
facility: 07
city: Seoul
country: Korea, Republic of
facility: 09
city: Seoul
country: Korea, Republic of
facility: 10
city: Seoul
country: Korea, Republic of
facility: 12
city: Seoul
country: Korea, Republic of
facility: 13
city: Seoul
country: Korea, Republic of
facility: 14
city: Seoul
country: Korea, Republic of
facility: 17
city: Seoul
country: Korea, Republic of
facility: 18
city: Seoul
country: Korea, Republic of
facility: 20
city: Seoul
country: Korea, Republic of
facility: 21
city: Seoul
country: Korea, Republic of
facility: 22
city: Seoul
country: Korea, Republic of
facility: 27
city: Yangsan
country: Korea, Republic of
facility: 25
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B. Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease. Expert Opin Pharmacother. 2016 Aug;17(11):1453-61. doi: 10.1080/14656566.2016.1202917. Epub 2016 Jul 7.