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Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Study acronym: POUIA
StatusSuspended
PhaseNot applicable
Started
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Record History

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  1. Recruitment suspended Sponsor's reason: IRB approval has lapsed. Study has submitted continuing review report for re-certification. Awaiting IRB re-approval. Show 6 more changesShow less
    • Primary completion pushed from Sep 2026 to Dec 2027
    • Study completion pushed from Sep 2027 to Dec 2028
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Site details revised
    • Publications: details revised at 18 of 18 entries
  2. Phase: Not specified to Not applicablev5 Show 5 more changesShow less
    • Enrollment target: 200 to 120
    • Primary completion date: Mar 2026 to Sep 2026
    • Study completion date: Mar 2026 to Sep 2027
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints revised (8)
  3. Interventions: Clipping (Procedure), Endovascular embolization (Procedure) to Clipping (Procedure), Endovascular embolization (Procedure), Surveillance imaging (Diagnostic Test)v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2023 to Dec 1, 2023
    • Site details revised
    v3
  5. Interventions: Clipping (Procedure), Endovascular embolization (Device) to Clipping (Procedure), Endovascular embolization (Procedure)v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Montefiore Medical Center
119 trials monitored
See 20 trials at risk
Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.
Trial Details
NCT Number NCT06123325
Lead Sponsor Montefiore Medical Center
Collaborators: The Bee Foundation
Conditions
(from sponsor)		 Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1
Related terms Anxiety Disorders, Depression, Intracranial Aneurysm
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov