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

Sponsor
CHU de Reims (Other)
Overall Status
Completed
CT.gov ID
NCT02866812
Collaborator
(none)
133
1
1
66
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaires assessing the state of fatigue, depression and anxiety
N/A

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm
Actual Study Start Date :
Mar 17, 2016
Actual Primary Completion Date :
Feb 17, 2021
Actual Study Completion Date :
Sep 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: patient with endovascular treatment for intracranial aneurysm

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

Outcome Measures

Primary Outcome Measures

  1. depression [6 months]

    Depression evaluated using the Hamilton scale

Secondary Outcome Measures

  1. tired [6 months]

    tired evaluated using the Piper scale

  2. anxiety [6 months]

    tired evaluated using the State - Trait Anxiety Inventory Form Y

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Reims Reims France 51092

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT02866812
Other Study ID Numbers:
  • PA15099
First Posted:
Aug 15, 2016
Last Update Posted:
Jan 13, 2022
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022