Impulse Control Disorder
Conditions
Brief summary
The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated with dopaminergic medications.
Detailed description
* PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward) * SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF
Interventions
DRUGLevodopa/Carbidopa(200mg/50mg)
DRUGDopaminergic Agonists
Treated for at least 6 months after diagnosis of Parkinson's Disease.
Sponsors
Sandoz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's Disease Brain Bank Criteria * mMIDI ≥ 3 score with ICD * Patients must be on an anti-parkinson treatment at least 6 months before screening. * for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment. * 30years ≤ patients \< 80years of age, male or female * patients must give written informed consent before any assessment is performed
Exclusion criteria
* Requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future * for the patients ≤ 65years: K-MMSE(korean version of Mini-Mental State Exam) ≤24, or for the patients ≥ 66years: K-MMSE ≤ 20, or the patients have dementia(incl. early dementia) even though K-MMSE score is more than 20 * Requirement of treatment more than 6times per day due to the severe motor fluctuation. * Severe dyskinesia * DBS(Deep Brain Stimulation)or any other surgical treatment * History of melanoma or not-diagnostic skin trouble/skin lesions * narrow angle glaucoma * clinically serious surgical or medical condition * malignant tumor * use of other investigational drugs at the time of enrollment within 4weeks * pregnant, nursing or lactating women * women of child-bearing potential * history of hypersensitivity or allergy to levodopa/carbidopa * any serious disease according to the investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mMIDI(modified Minnesota Impulsive Disorders Interview) | 12weeks | To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric profile | 12 weeks | To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF \* Neuropsychological assessment * General cognitive status: K-Minimental status exam(K-MMSE) * Psychiatric profile: * Neuropsychiatric inventory (K-NPI) * Beck depression inventory (BDI) * Barratt impulsiveness scale (BIS) * Beck anxiety inventory (BAI) * State-trait anger expression inventory (STAXI) * Obsessive compulsive inventory (OCI) * Evaluation of global change: * Patient global impression of improvement (PGI-I) * Clinical global impression of improvement (CGI-I) |
Countries
South Korea
Outcome results
None listed