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Thermoregulation Among Individuals With First-episode Psychosis

Thermoregulation Among Individuals With First-episode Psychosis

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04369677
Enrollment
0
Registered
2020-04-30
Start date
2017-01-17
Completion date
2025-04-03
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis, Psychosis

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.

Interventions

None listed

Sponsors

Nicholas Breitborde
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

Eligibility for Individuals with First-Episode Psychosis: 1. Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5 . 2. Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory. 3. No evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4. Eligibility for Individuals without First-Episode Psychosis: 1. No diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5. 2. No evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4. Eligibility for Individuals with and without First-Episode Psychosis: 1. Ages 18 - 35 2. No evidence of swallowing difficulties as assessed using the Swallowing Disturbance Questionnaire \[SDQ\]. defined as (i) a score \<5 on the SDQ oral phase questions, (ii) a score \<11.5 on the laryngopharygeal phase SDQ questions, and a total SDQ score \< 12.5. 3. Not meeting diagnostic criteria for a substance use disorder over the past month as determined using the Structured Clinical Interview for the DSM-5 . 4. No current or past diagnosis of a medical condition known to affect thermoregulatory Functioning as assessed using the Health Conditions that Affect Thermoregulation questionnaire 5. Per recommendations from the manufacturer of the CorTemp continuous temperature sensor, we will not enroll: 1. Individuals who weigh less than 80 pounds 2. Individuals diagnosed with known or suspected obstructive diseases of the gastrointestinal tract 3. Individuals with a history of gag reflex disorders or impairments 4. Individuals with previous or scheduled gastrointestinal surgery 5. Individuals having felinization of the esophagus 6. Individuals with conditions that would result in hypomotility of the GI tract. 7. Individuals scheduled to undergo Magnetic Resonance Imaging or Nuclear Magnetic Resonance in the next month 8. Individuals with cardiac pacemaker or other implanted electric medical devices

Design outcomes

Primary

MeasureTime frameDescription
Differences in mean temperature and diurnal temperature variation24 hour intervalsDifferences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis.
Differences in mean temperature and temperature variation during periods of rest and activity24 hour intervalsDifferences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis.
Association of core body temperature and ratings of psychotic symptomatology in FEP24 hour intervalsAssociation between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026