NCT04369677

Thermoregulation Among Individuals With First-episode Psychosis

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Nicholas Breitborde · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psychosis
• First Episode Psychosis

Timeline

• Start date: 2017-01-17
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2020-04-30
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States