Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram

• Conditions: Depression, anxiety and ICD; MedDRA version: 14.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2007-004009-93-IT
• Lead Sponsor: DBECK ITALIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-14
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified