NCT06123325 Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
| NCT ID | NCT06123325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Anxiety Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-12-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 Subarachnoid Hemorrhage (SAH) * Prior history of intracranial aneurysm * Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases * Traumatic, mycotic, dissecting, or fusiform aneurysms * Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments * Patients with any physical disabilities or handicaps
Contact & Investigator
David J Altschul, MD
PRINCIPAL INVESTIGATOR
Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore
Frequently Asked Questions
Who can join the NCT06123325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Anxiety Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06123325 currently recruiting?
Yes, NCT06123325 is actively recruiting participants. Contact the research team at muhammedamir.essibayi@einsteinmed.edu for enrollment information.
Where is the NCT06123325 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06123325 clinical trial?
NCT06123325 is sponsored by Montefiore Medical Center. The principal investigator is David J Altschul, MD at Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore. The trial plans to enroll 120 participants.
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