Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm (DEP-AIC)
Primary Purpose
Intracranial Aneurysm
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaires assessing the state of fatigue, depression and anxiety
Sponsored by
About this trial
This is an interventional basic science trial for Intracranial Aneurysm
Eligibility Criteria
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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with endovascular treatment for intracranial aneurysm
Arm Description
Outcomes
Primary Outcome Measures
depression
Depression evaluated using the Hamilton scale
Secondary Outcome Measures
tired
tired evaluated using the Piper scale
anxiety
tired evaluated using the State - Trait Anxiety Inventory Form Y
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02866812
Brief Title
Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm
Acronym
DEP-AIC
Official Title
Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2016 (Actual)
Primary Completion Date
February 17, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief 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.
Detailed 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with endovascular treatment for intracranial aneurysm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
questionnaires assessing the state of fatigue, depression and anxiety
Primary Outcome Measure Information:
Title
depression
Description
Depression evaluated using the Hamilton scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
tired
Description
tired evaluated using the Piper scale
Time Frame
6 months
Title
anxiety
Description
tired evaluated using the State - Trait Anxiety Inventory Form Y
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm
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