Clinical trial NCT01055379: Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Symptoms
Parkinson's Disease
Keywords: Rasagiline
Depressive Symptoms
Cognition
Lead sponsor: Lundbeck Italia S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2010-01-25
Enrollment: 121
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary endpoint for this study is the clinical response after 12 weeks of treatment, defined as a change in total score from baseline depressive symptoms as measured by the Beck Depression Inventory-Amended (BDI-IA) total score.

Detailed description: ACCORDO is a multicentre, randomised, double-blind, and placebo-controlled study conducted in 12 Italian centres. Subjects are screened by means of the BDI-IA (cut-off 15) and randomised to treatment with rasagiline or placebo for 12 weeks.

Subjects have to be on stable treatment with dopaminergic agents at least 4 weeks before baseline, and maintained so during the course of the study.

The primary objective is to evaluate whether rasagiline compared to placebo improves depressive symptoms as evaluated by the BDI-IA total score.

Eligibility criteria: Inclusion Criteria:

* Outpatient, male or female aged \>=40 and \<80 years. The subject has a diagnosis of idiopathic Parkinson's Disease (PD) according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria for PD for the clinical diagnosis of PD.
* Depressive symptoms with a minimum severity of \>=15 using the BDI-IA.
* Hoehn and Yahr stage I-III.
* Under stable (4 weeks prior to baseline) dopaminergic treatment without significant motor complication such as "on-off" phenomena and/or dyskinesia.
* The subject and/or legal representative and/or impartial witness is/are able to read and understand the Subject Information Sheet.
* The subject and/or legal representative has/have signed the Informed Consent Form (ICF) and if relevant the impartial witness has co-signed the ICF.
* If female, must: agree not to try to become pregnant during the study (female patients of childbearing potential will take pregnancy test, using a urine stick), AND use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicidal, or condom for male partner in combination with spermicidal), OR have been menopausal for at least 24 months prior to baseline, (OR) have been surgically sterilised prior to baseline, OR have had a hysterectomy prior to baseline.

Exclusion Criteria:

A subject, who meets one or more of the following criteria at the Baseline Visit, is not eligible for inclusion in this study:

* Motor complications such as wearing off and on-off phenomena.
* Mini-Mental State Examination (MMSE) \<26, corrected score.
* Diagnosis of current or history of major depressive episode according to DSM-IV-TR® criteria within 1 year before recruitment into the study.
* Presence of any other neurodegenerative disorder other than PD, based on judgement of investigator.
* Psychotic symptoms, e.g. hallucination and delirium (determined by clinical evaluation).
* Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, or renal failure.
* Use of any prohibited concomitant medication according to the timelines provided in Appendix II.
* Patient who have undergone Deep Brain Stimulation surgery.
* Current treatment with antidepressants or history of treatment with antidepressants less than 1 month prior to randomisation.
* Current treatment or history of treatment less than 1 month prior to randomisation, with antipsychotics, cholinesterase inhibitors, memantine, amantadine, or anticholinergics.
* Current treatment with selegiline or history of treatment with selegiline less than 90 days prior to randomisation.

Primary outcomes:
measure: Change from baseline in BDI-IA total score
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluate if rasagiline compared to placebo improves cognitive function, over a treatment period of 12 weeks in idiopathic Parkinson´s Disease, using a formal neuropsychiatric cognitive test battery; quality of life (PDQ 39); apathy; ADL, motor function
timeFrame: 12 weeks
measure: Change in quality of life using the PDQ-39 scale
timeFrame: 12 weeks
measure: Change in apathy using the Apathy Scale
timeFrame: 12 weeks
measure: Change in ADL and motor function using UPDRS scales part II and III, respectively
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: IT010
city: Chieti
country: Italy
facility: IT007
city: Genova
country: Italy
facility: IT004
city: Lido di Camaiore
country: Italy
facility: IT005
city: Messina
country: Italy
facility: IT003
city: Milano
country: Italy
facility: IT012
city: Naples
country: Italy
facility: IT001
city: Roma
country: Italy
facility: IT011
city: Rome
country: Italy
facility: IT008
city: Torino
country: Italy
facility: IT015
city: Venezia
country: Italy
facility: IT013
city: Verona
country: Italy
facility: IT009
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: