Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02866812
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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
Intracranial Aneurysm Other: questionnaires assessing the state of fatigue, depression and anxiety Not Applicable

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
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 : March 17, 2016
Estimated Primary Completion Date : March 17, 2021
Estimated Study Completion Date : September 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patient with endovascular treatment for intracranial aneurysm Other: questionnaires assessing the state of fatigue, depression and anxiety



Primary Outcome Measures :
  1. depression [ Time Frame: 6 months ]
    Depression evaluated using the Hamilton scale


Secondary Outcome Measures :
  1. tired [ Time Frame: 6 months ]
    tired evaluated using the Piper scale

  2. anxiety [ Time Frame: 6 months ]
    tired evaluated using the State - Trait Anxiety Inventory Form Y



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866812


Contacts
Layout table for location contacts
Contact: Sébastien SOIZE ssoize@chu-reims.fr

Locations
Layout table for location information
France
Chu de Reims Recruiting
Reims, France, 51092
Contact: Sébastien SOIZE       ssoize@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Layout table for additonal information
Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02866812     History of Changes
Other Study ID Numbers: PA15099
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Aneurysm
Depression
Behavioral Symptoms
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases