Overuse of Antidepressant in Patients With Alzheimer Disease

NCT02529436 | Completed

• 1 other identifier: AD2015
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population. Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in prescription duration) Main objective: to assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in prescription duration) in patients aged 70 years and over with ADAD. Secondary objectives:

1. 1.To assess the prevalence of AD prescribed for a non validated indication
2. 2.To assess the prevalence of AD prescribed with excess in prescription duration
3. 3.To assess the prevalence of psychotropic coprescription and notably the prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health
4. 4.To assess factors associated to AD overuse Method: A transversal monocentric study in the geriatric day Bretonneau unit will be performed. Study will be proposed to all eligible patients (with non-opposition of the patient or of his legal representative to the collection of his personal data). Included people will have no supplementary clinical or complementary investigations. The geriatrician in charge will have to systematically collect the indication and the history of the AD treatment. At the end of the evaluation performed in the geriatric day unit, the geriatrician will have to conclude to the AD overuse or not associated with off label prescription. Doubtful case will be examined by a validation committee.

Conditions

Alzheimer Disease

Keywords

overuse antidepressant; dementia

Outcome Measures

Primary Outcomes (1)

• AD overuse with off label prescriptions, ie no validated indication or excess in prescription duration.

  Indication for AD will be the one declared by the prescriber of AD. Off label prescription will be defined by prescription for indication not listed in the Summary of Product Characteristics (SPC). Prescription duration will be considered as exceeded if superior to that recommended in market authorization : Duration\>14 months in major depressive disorder and in patient with remission Exceeded duration according to the geriatrician in charge according to the multidisciplinary evaluation performed during the geriatric day hospital . If the geriatrician could not conclude, an expert committee (including a psycho-geriatrician and a geriatrician expert in drug) will adjudicate to the overuse or not of the AD.

  At inclusion

Secondary Outcomes (7)

• Prevalence of psychotropic coprescription

  At inclusion

• Prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health

  At inclusion

• Type and severity of dementia (Mini Mental Status, Frontal Assessment Battery, stage of dementia, etiological diagnosis)

  At inclusion

• Comorbidities

  At inclusion

• Coprescription, type and number of prescriber(s)

  At inclusion

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seniors (age 70 or older) with dementia on antidepressants.

You may qualify if:

• Age ≥70 years,
• Dementia according to DSMIV criteria, whatever its level,
• Antidepressant prescription.

You may not qualify if:

• Refusal of the patient or of his legal representative to the collection of his personal data,
• Mild Cognitive Impairment.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bretonneau

Paris, 75018, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dominique BONNET-ZAMPONI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 20, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

FR (1)