Phase 4
N=380
Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Idiopathic Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01523301 ↗Enrolled (actual)
380
Serious AEs
5.3%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) — -4.79; -3.68 units on a scale — p==0.1286
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rotigotine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- UCB Korea Co., Ltd.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D) |
-4.79; -3.68 | =0.1286 |
| SECONDARY Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II) |
-5.87; -4.68 | — |
| SECONDARY 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) |
-1.13; -0.10 | — |
| SECONDARY Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) |
-3.07; -1.65 | — |
| SECONDARY 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) |
-4.20; -1.81 | — |
| SECONDARY Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS) |
-1.93; -0.67 | — |
| SECONDARY Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS) |
-0.82; -0.60 | — |
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
Data sourced from ClinicalTrials.gov (NCT01523301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.