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

NCT ID: NCT01055379

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Depressive Symptoms; Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rasagiline

Group Type: EXPERIMENTAL

Rasagiline

Intervention Type: DRUG

1 mg/day for 12 weeks; orally

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily for 12 weeks; orally

Interventions

Rasagiline

1 mg/day for 12 weeks; orally

Intervention Type: DRUG

Placebo

Once daily for 12 weeks; orally

Intervention Type: DRUG

Other Intervention Names

Azilect

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: collaborator

Lundbeck Italia S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

IT010

Cagliari, , Italy

IT007

Chieti, , Italy

IT004

Genova, , Italy

IT005

Lido di Camaiore, , Italy

IT003

Messina, , Italy

IT012

Milan, , Italy

IT001

Naples, , Italy

IT011

Roma, , Italy

IT008

Rome, , Italy

IT015

Torino, , Italy

IT013

Venezia, , Italy

IT009

Verona, , Italy

Countries

Italy

Study Documents

Document Type: EMA EudraCT Results

View Document

Other Identifiers

2009-011144-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12962A

Identifier Type: -

Identifier Source: org_study_id