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
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|
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 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|
|Experimental: patient with endovascular treatment for intracranial aneurysm||
Other: questionnaires assessing the state of fatigue, depression and anxiety
- depression [ Time Frame: 6 months ]Depression evaluated using the Hamilton scale
- tired [ Time Frame: 6 months ]tired evaluated using the Piper scale
- anxiety [ Time Frame: 6 months ]tired evaluated using the State - Trait Anxiety Inventory Form Y
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866812
|Contact: Sébastien SOIZEfirstname.lastname@example.org|
|Chu de Reims||Recruiting|
|Reims, France, 51092|
|Contact: Sébastien SOIZE email@example.com|