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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Recruitment Status : Withdrawn (lack of funding)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

Tracking Information
First Submitted Date April 27, 2020
First Posted Date April 30, 2020
Last Update Posted Date January 19, 2024
Estimated Study Start Date November 1, 2023
Estimated Primary Completion Date April 3, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thermoregulation Among Individuals With First-episode Psychosis
Official Title Thermoregulation Among Individuals With First-episode 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Psychosis
  • First Episode Psychosis
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 17, 2024)		 0
Original Estimated Enrollment
 (submitted: April 27, 2020)		 20
Estimated Study Completion Date April 3, 2025
Estimated Primary Completion Date April 3, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369677
Other Study ID Numbers 2020H0066
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Nicholas Breitborde, Ohio State University
Original Responsible Party Same as current
Current Study Sponsor Nicholas Breitborde
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Ohio State University
Verification Date January 2024