Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm

Intracranial Aneurysm Clinical Trial

— DEP-AIC  

Official title:

Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866812
• Other study ID #: PA15099
• Status: Completed
• Phase: N/A
• Start date: March 17, 2016
• Est. completion date: September 17, 2021

Study information

• Verified date: December 2021
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. At the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams.

Regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. Depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. This description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities).

Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. They would present an cognitive impairment in one case in five at 1 month of treatment.

If depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.

A precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.

Description:

Describe the prevalence of depression among patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mRS inferior or egal to 1).

Study factors associated with the presence of depression in patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mRS inferior or egal to 1)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient with endovascular treatment for intracranial aneurysm (ruptured or unruptured)

• patient older than 18 years

• patient consenting to participate to the study

• patient enrolled in the national healthcare insurance program

Exclusion Criteria:

• patient with anterior treatment for intracranial aneurysm

• bipolar disorder, schizophrenia or schizoaffective disorder diagnostic

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Other:
• questionnaires assessing the state of fatigue, depression and anxiety

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depression	Depression evaluated using the Hamilton scale	6 months
Secondary	tired	tired evaluated using the Piper scale	6 months
Secondary	anxiety	tired evaluated using the State - Trait Anxiety Inventory Form Y	6 months