Clinical Trial: Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's

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 Summary:

  • 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

Sponsor: Sandoz

Current Primary Outcome: mMIDI(modified Minnesota Impulsive Disorders Interview) [ Time Frame: 12weeks ]

To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)


Original Primary Outcome: mMIDI [ Time Frame: 12weeks ]

Current Secondary Outcome: Neuropsychiatric profile [ Time Frame: 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)


Original Secondary Outcome:

Information By: Sandoz

Dates:
Date Received: September 7, 2012
Date Started: November 2012
Date Completion: June 2013
Last Updated: October 10, 2012
Last Verified: October 2012