Status:
WITHDRAWN
Thermoregulation Among Individuals With First-episode Psychosis
Lead Sponsor:
Nicholas Breitborde
Conditions:
Psychosis
First Episode Psychosis
Eligibility:
All Genders
18-35 years
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 mea...
Eligibility Criteria
Inclusion
- Eligibility for Individuals with First-Episode Psychosis:
- Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5 .
- Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory.
- 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:
- No diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
- 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:
- Ages 18 - 35
- 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.
- Not meeting diagnostic criteria for a substance use disorder over the past month as determined using the Structured Clinical Interview for the DSM-5 .
- No current or past diagnosis of a medical condition known to affect thermoregulatory Functioning as assessed using the Health Conditions that Affect Thermoregulation questionnaire
- Per recommendations from the manufacturer of the CorTemp continuous temperature sensor, we will not enroll:
- Individuals who weigh less than 80 pounds
- Individuals diagnosed with known or suspected obstructive diseases of the gastrointestinal tract
- Individuals with a history of gag reflex disorders or impairments
- Individuals with previous or scheduled gastrointestinal surgery
- Individuals having felinization of the esophagus
- Individuals with conditions that would result in hypomotility of the GI tract.
- Individuals scheduled to undergo Magnetic Resonance Imaging or Nuclear Magnetic Resonance in the next month
- Individuals with cardiac pacemaker or other implanted electric medical devices
Exclusion
Key Trial Info
Start Date :
January 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04369677
Start Date
January 17 2017
End Date
April 3 2025
Last Update
October 30 2024
Active Locations (1)
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1
Harding Hospital
Columbus, Ohio, United States, 43210