Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm
DEP-AIC
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2016
CompletedFirst Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2021
CompletedJanuary 13, 2022
December 1, 2021
4.9 years
August 10, 2016
December 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
depression
Depression evaluated using the Hamilton scale
6 months
Secondary Outcomes (2)
tired
6 months
anxiety
6 months
Study Arms (1)
patient with endovascular treatment for intracranial aneurysm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient with anterior treatment for intracranial aneurysm
- bipolar disorder, schizophrenia or schizoaffective disorder diagnostic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu de Reims
Reims, 51092, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 15, 2016
Study Start
March 17, 2016
Primary Completion
February 17, 2021
Study Completion
September 17, 2021
Last Updated
January 13, 2022
Record last verified: 2021-12