Thermoregulation Among Individuals With First-episode Psychosis

NCT04369677 | Withdrawn

• 1 other identifier: 2020H0066
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychosis; First Episode Psychosis

Outcome Measures

Primary Outcomes (3)

• Differences in mean temperature and diurnal temperature variation

  Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis.

  24 hour intervals

• Differences in mean temperature and temperature variation during periods of rest and activity

  Differences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis.

  24 hour intervals

• Association of core body temperature and ratings of psychotic symptomatology in FEP

  Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.

  24 hour intervals

Study Arms (2)

First-Episode Psychosis

Twenty individuals with FEP will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL).

Healthy

Twenty age-matched individuals with no psychotic disorder will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL).

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nicholas Breitborde: lead

Study Sites (1)

Harding Hospital

Columbus, Ohio, 43210, United States

Location

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MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: January 17, 2017
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)