Depression, anxiety and ICD MedDRA version: 14.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: CIPRALEX
Pharmaceutical Form: Tablet
INN or Proposed INN: Escitalopram
Concentration unit: mg milligram(s)
Concentration number: 10-
Trade Name: CIPRALEX
Pharmaceutical Form: Tablet
INN o
Sponsors
LUNDBECK ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ Male or female and aged ≥18 years ¿ Diagnosis of Parkinson Disease according to UK Brain Bank criteria ¿ Diagnosis of major depression, minor depression, anxiety disorder (GAD, SAD, panic disorder) impulse control disorder (ICD) according to DSM IV TR criteria ¿ Current treatment with levodopa and/or dopaminergic agonists orally administered ¿ The daily dose of levodopa and dopaminergic agonist have been stable for at least the last 2 months prior to enrolment ¿ Patients are in stage I-II according to H&Y scale ¿ Patients must have signed the informed consent form to study participation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has a terminal illness or a severe general medical condition or has a positive HIV test at entry¿. 2. The patient is suffering from a neurological or psychiatric disease other than PD or affective disorder 3. The patient has concomitant, moderate to severe dementia (MMSE 20) 4. The patient has any condition that could impose hazards to the patient (including suicidal risk) if study therapy is initiated, or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator. 5. The patient is a woman with any childbirth potential 6. The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason 7. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening 8. The patient is currently treated with non selective I-MAO or moclobemide (selective reversible MAO-A) or has been treated with non selective I-MAO or moclobemide within 14 days prior to enrolment. 9. The patient has a history of lack of response to escitalopram 10. The patient has a history of severe drug allergy or hypersensitivity to escitalopram or any of product components within 30 days or 5 half lives (whichever is longer) prior to screening ¿ The patient is currently treated with non selective I-MAO or have been treated with non selective I-MAO within 14 days prior to enrolment. ¿ The patient has a history of lack of response to escitalopram ¿ The patient has a history of severe drug allergy or hypersensitivity to escitalopram or any of product components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present study is to evaluate the efficacy and safety of escitalopram 10-20 mg/die in depression, anxiety or impulse control disorder (ICD) symptoms in patients suffering from Parkinson disease (efficacy objective) after assessing the prevalence of ICD - anxiety ¿ depression in out-patient Parkinson clinic (epidemiological objective).;Secondary Objective: The secondary objectives are: to investigate possible relationship between changes in anxiety symptoms (HAM-A), depressive symptoms (HAM-D, BDI), compulsive behaviour symptoms (PI, SCL-90) and changes in levodopa or dopaminergic drugs self-administration; to evaluate the changes in UPDRS over time, changes in daily off¿time (self-administered with VAS) and changes in ADL (UPDRS-II) and QoL (PDQ-39);Primary end point(s): Primary variables: The primary efficacy assessments will be based on the following evaluation tools for each diagnostic group: Depression: HAM-D Anxiety: HAM-A ICD: PI Primary end point will be the change from baseline of reference scale for each diagnostic group | — |
Countries
Italy
Outcome results
None listed