ACCORDO: Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn

Sponsor

Lundbeck Italia S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01055379

Collaborator

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

121

Enrollment

Locations

Arms

Duration (Months)

10.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms Parkinson's Disease	Drug: Rasagiline Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rasagiline	Drug: Rasagiline 1 mg/day for 12 weeks; orally Other Names: Azilect
Placebo Comparator: Placebo	Drug: Placebo Once daily for 12 weeks; orally

Arm

Intervention/Treatment

Experimental: Rasagiline

Drug: Rasagiline

1 mg/day for 12 weeks; orally

Other Names:

Azilect

Placebo Comparator: Placebo

Drug: Placebo

Once daily for 12 weeks; orally

Outcome Measures

Primary Outcome Measures

Change from baseline in BDI-IA total score [12 weeks]

Secondary Outcome Measures

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 [12 weeks]
Change in quality of life using the PDQ-39 scale [12 weeks]
Change in apathy using the Apathy Scale [12 weeks]
Change in ADL and motor function using UPDRS scales part II and III, respectively [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	IT010	Cagliari	Italy	9134
2	IT007	Chieti	Italy	66013
3	IT004	Genova	Italy	16132
4	IT005	Lido di Camaiore	Italy	55043
5	IT003	Messina	Italy	98122
6	IT012	Milano	Italy	20135
7	IT001	Naples	Italy	80131
8	IT011	Roma	Italy	161
9	IT008	Rome	Italy	133
10	IT015	Torino	Italy	10126
11	IT013	Venezia	Italy	30126
12	IT009	Verona	Italy	37134