Depressive SymptomsPhase 4ACCORDONCT01055379
Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn
A Phase 4 study testing Rasagiline in people with Depressive Symptoms and Parkinson's Disease, run by Lundbeck Italia S.p.A. at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Depressive Symptoms, Parkinson's Disease
- What is being tested?
- Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 12 sitesItaly
- Study dates
- Mar 2010to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
IT010
Cagliari, 9134
IT007
Chieti, 66013
IT004
Genova, 16132
IT005
Lido di Camaiore, 55043
IT003
Messina, 98122
IT012
Milan, 20135
IT001
Naples, 80131
IT011
Roma, 161
IT008
Rome, 133
IT015
Torino, 10126
IT013
Venezia, 30126
IT009
Verona, 37134
About this study
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
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.
Read the 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
- Being tested
- Rasagiline, Placebo
- Keywords
- Rasagiline, Depressive Symptoms, Cognition
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Also called Azilect
1 mg/day for 12 weeks; orally
PlaceboDrug
Once daily for 12 weeks; orally
| Study group | Role | What they receive |
|---|---|---|
| Rasagiline | Experimental | Not described Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BDI-IA total score
Measured: 12 weeks
Secondary outcomes (4)
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
Measured: 12 weeks
Change in quality of life using the PDQ-39 scale
Measured: 12 weeks
Change in apathy using the Apathy Scale
Measured: 12 weeks
Change in ADL and motor function using UPDRS scales part II and III, respectively
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck Italia S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055379
- Sponsor's protocol ID
- 12962A
- Other IDs
- 2009-011144-19, 2009
- Acronym
- ACCORDO
- Status last verified
- Aug 2021
- First submitted
- 22 Jan 2010
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01055379
- Acronym / sponsor ID
- ACCORDO / 12962A
- Conditions
- Depressive Symptoms, Parkinson's Disease
- Keywords
- Rasagiline, Depressive Symptoms, Cognition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Lundbeck Italia S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rasagiline | Experimental | Drug: Rasagiline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RasagilineAlso: Azilect1 mg/day for 12 weeks; orally | Drug | Rasagiline |
| PlaceboOnce daily for 12 weeks; orally | Drug | Placebo |
Primary outcome
Change from baseline in BDI-IA total score
Time frame: 12 weeks
4 secondary outcomes
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
Change in quality of life using the PDQ-39 scale
Time frame: 12 weeks
Change in apathy using the Apathy Scale
Time frame: 12 weeks
Change in ADL and motor function using UPDRS scales part II and III, respectively
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasagiline in people with Depressive Symptoms and Parkinson's Disease, run by Lundbeck Italia S.p.A. at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BDI-IA total score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.