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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01055379
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : January 6, 2017
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Lundbeck Italia S.p.A.

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 Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change from baseline in BDI-IA total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]
  2. Change in quality of life using the PDQ-39 scale [ Time Frame: 12 weeks ]
  3. Change in apathy using the Apathy Scale [ Time Frame: 12 weeks ]
  4. Change in ADL and motor function using UPDRS scales part II and III, respectively [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01055379

Cagliari, Italy, 9134
Chieti, Italy, 66013
Genova, Italy, 16132
Lido di Camaiore, Italy, 55043
Messina, Italy, 98122
Milano, Italy, 20135
Naples, Italy, 80131
Roma, Italy, 161
Rome, Italy, 133
Torino, Italy, 10126
Venezia, Italy, 30126
Verona, Italy, 37134
Sponsors and Collaborators
Lundbeck Italia S.p.A.
Teva Pharmaceutical Industries
Study Director: Email contact via H. Lundbeck A/S

Study Data/Documents: EMA EudraCT Results  This link exits the site
Identifier: 2009-011144-19

Responsible Party: Lundbeck Italia S.p.A. Identifier: NCT01055379     History of Changes
Other Study ID Numbers: 12962A
2009-011144-19 ( EudraCT Number )
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Lundbeck Italia S.p.A.:
Depressive Symptoms

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Behavioral Symptoms
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs