Thermoregulation Among Individuals With First-episode Psychosis

Withdrawn

• Conditions: Psychosis; First Episode Psychosis

• Registration Number: NCT04369677
• Lead Sponsor: Nicholas Breitborde

Brief Summary

The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.

Detailed Description

The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.

Aim 1: Assess whether individuals with first-episode psychosis have differences in mean temperature and diurnal temperature variation as compared to individuals without psychosis.

Aim 2: Examine whether mean temperature and temperature variation during periods of rest and activity are different between individuals with first-episode psychosis versus people without psychosis.

Aim 3: Explore the association between current core body temperature and current ratings of psychotic symptomatology among individuals with first-episode psychosis.

Study participants will complete baseline assessments (e.g., symptoms, functioning, and sleep) and then complete a 24-36 hour ambulatory assessment period in which core temperature, activity, sleep, and heart rate variability will be tracked continuously and symptom severity will be assessed sporadically using a symptom rating app on their smart phone. .Then they will complete a second study visit to repeat baseline assessments.

Study Timeline

• Study Start: 2017-01-17
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in mean temperature and temperature variation during periods of rest and activity	24 hour intervals	Differences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis.
Differences in mean temperature and diurnal temperature variation	24 hour intervals	Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis.
Association of core body temperature and ratings of psychotic symptomatology in FEP	24 hour intervals	Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.

Trial Locations

Locations (1)

Harding Hospital; 🇺🇸 Columbus, Ohio, United States