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NCT06123325 · ClinicalTrials.gov registry record · NA

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

A NA study of Mental Health Wellness 1 and Anxiety Depression, sponsored by Montefiore Medical Center.

Recruiting
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT06123325 is a NA study of Mental Health Wellness 1 and Anxiety Depression that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 723-participant average among 20 other Mental Health Wellness 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06123325, a NA study of Mental Health Wellness 1 and Anxiety Depression, is actively recruiting participants, sponsored by Montefiore Medical Center.

RECRUITING
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • PROCEDURE Clipping
  • PROCEDURE Endovascular embolization
  • DIAGNOSTIC_TEST Surveillance imaging

Study Locations (1)

New York

  • Montefiore Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-12-01
Est. Completion 2027-09
Phase NA

Sponsor

Montefiore Medical Center

345 total trials

What the Registry Record Tells You About NCT06123325

The ClinicalTrials.gov registry entry for NCT06123325 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 723-participant average among 20 other Mental Health Wellness 1 trials with a reported enrollment target (83% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Mental Health Wellness 1 appearing as the primary indexed condition, and to 3 interventions - of which Clipping is the first listed.

NCT06123325 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT06123325 about?

NCT06123325 is a clinical study titled "Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)". 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 populati...

What is the current status of trial NCT06123325?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-12-01. Estimated completion is 2027-09.

What conditions does trial NCT06123325 study?

This clinical trial studies the following conditions: Mental Health Wellness 1, Anxiety Depression, Aneurysm Cerebral.

What interventions are being tested in trial NCT06123325?

The interventions under investigation include: Clipping (PROCEDURE), Endovascular embolization (PROCEDURE), Surveillance imaging (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06123325?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06123325 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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