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Search / Trial NCT06123325

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Launched by MONTEFIORE MEDICAL CENTER · Nov 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cerebral Aneurysm Anxiety Depression Endovascular Clipping

ClinConnect Summary

The Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA) trial is studying how the diagnosis of an unruptured intracranial aneurysm (a bulge in a blood vessel in the brain that hasn’t burst) affects patients' mental health, particularly their levels of anxiety and depression. Many people with this condition may not need immediate treatment, and the study aims to understand how simply being aware of having an aneurysm influences their psychological well-being. Researchers will use a survey called the Hospital Anxiety and Depression Scale (HADS) to assess participants' mental health.

To participate in this trial, patients must have an unruptured intracranial aneurysm that is smaller than 4 mm or is in a location not suitable for immediate treatment. Participants should also be relatively healthy, with no severe mental health issues or prior history of brain bleeding. This study is open to all adults aged 18 and older, and as it is currently recruiting, eligible participants can expect to share their experiences and complete questionnaires about their mental health. Understanding the psychological impact of these diagnoses can lead to better support and care for patients facing this condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Unruptured intracranial aneurysms (UIA)
  • mRS scores between 0-1
  • Observation Group: All patients with UIAs that are eligible for conservative management.
  • 1. Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms.
  • 2. Aneurysm size (largest dimension) is less than 4 mm.
  • Treatment Group: All Patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision.
  • Exclusion Criteria:
  • Prior history of intracranial hemorrhage.
  • Prior history of intracranial aneurysm
  • Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases.

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

David J Altschul, MD

Principal Investigator

Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported