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NCT04325568 · ClinicalTrials.gov registry record · Phase 1

Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis

A Phase 1 study, sponsored by New York University.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT04325568: Completed Phase 1 study, sponsored by New York University.

NCT04325568 is a Phase 1 study that has completed, run by New York University. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04325568, a Phase 1 study, has completed, sponsored by New York University.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

While great strides are being made in identifying early signs that place people at a 'high risk state' for different illness conditions, at the same time, advances are being made in the identification of genes associated with 'high-risk states'. This study proposes to develop two innovative clinical tools that could greatly facilitate dissemination of a beneficial genetic malleability framing to high-risk youth in order to encourage increased treatment engagement and uptake of healthy behaviors. The impact of genetic information assumes special importance in the 'high-risk state' because achieving the best possible outcome is more likely if individuals actively choose to engage in beneficial treatment and health-promoting behaviors.

Primary Outcome

Asks participants to rate the likelihood that engaging in treatment and adaptive behaviors will reduce the risk for developing psychosis, if they were told they had a genetic risk for psychosis. Items are measured on a 4-point scale (1=very unlikely, 2=somewhat unlikely, 3=somewhat likely, 4=very likely), with higher scores indicating greater perceived efficacy. Measure is divided into four sub-scales: a) avoiding unhealthy behaviors (4 items range 4-16), b) engaging in healthy behaviors (5 item

Interventions

  • BEHAVIORAL PsyGist and Clinician Manual

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-11-16
Est. Completion 2022-07-31
Phase Phase 1
New York University

83 total trials

What the finished NCT04325568 record still lists

NCT04325568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which PsyGist and Clinician Manual is the first listed.

NCT04325568 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04325568 about?

NCT04325568 is a clinical study titled "Developing Clinical Tools to Communicate Genetic Risk for Individuals Who Are Clinical High Risk for Psychosis". While great strides are being made in identifying early signs that place people at a 'high risk state' for different illness conditions, at the same time, advances are being made in the identification of genes associated with 'high-risk states'. This study proposes to develop two innovative clinical...

What is the current status of trial NCT04325568?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-11-16. Estimated completion is 2022-07-31.

What interventions are being tested in trial NCT04325568?

The interventions under investigation include: PsyGist and Clinician Manual (BEHAVIORAL).

Who is sponsoring clinical trial NCT04325568?

This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04325568's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04325568, the US trial registry maintained by the National Library of Medicine. NCT04325568 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.