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Thermoregulation Among Individuals With First-episode Psychosis

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ClinicalTrials.gov Identifier: NCT04369677
Recruitment Status : Withdrawn (lack of funding)
First Posted : April 30, 2020
Last Update Posted : January 19, 2024
Sponsor:
Information provided by (Responsible Party):
Nicholas Breitborde, Ohio State University

Study Description
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Brief Summary:
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.

Condition or disease
Psychosis 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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Thermoregulation Among Individuals With First-episode Psychosis
Estimated Study Start Date : November 1, 2023
Estimated Primary Completion Date : April 3, 2025
Estimated Study Completion Date : April 3, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. Differences in mean temperature and diurnal temperature variation [ Time Frame: 24 hour intervals ]
    Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis.

  2. Differences in mean temperature and temperature variation during periods of rest and activity [ Time Frame: 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.

  3. Association of core body temperature and ratings of psychotic symptomatology in FEP [ Time Frame: 24 hour intervals ]
    Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369677


Locations
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United States, Ohio
Harding Hospital
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Nicholas Breitborde
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
First, M.B., et al., Structured Clinical Interview for DSM-5-Research Version2015, Arlington, VA: American Psychiatric Association.
Wilkinson, G.S. and G.J. Robertson, Wide Range Achievement Test (WRAT4)2006, Lutz, FL: PAR, Inc
Auther, A., C. Smith, and B. Cornblatt, Global Functioning: Social Scale (GF: Social). Glen Oaks, NY: Zucker-Hillside Hospital, 2006.
Niendam, T., et al., Global Functioning: Role Scale (GF: Role). Los Angeles, CA: University of California, Los Angeles, 2006.
Hays, R.D., S. Prince-Embury, and H.Y. Chen, RAND-36 Health Status Inventory1998, San Antonio, TX: The Psychological Corporation.

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Responsible Party: Nicholas Breitborde, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04369677    
Other Study ID Numbers: 2020H0066
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: January 19, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders