Thermoregulation Among Individuals With First-episode Psychosis

Psychosis Clinical Trial

Official title:

Thermoregulation Among Individuals With First-episode Psychosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04369677
• Other study ID #: 2020H0066
• Status: Withdrawn
• Start date: November 1, 2023
• Est. completion date: April 3, 2025

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 3, 2025
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• First Episode Psychosis
• Mental Disorders
• Psychosis
• Psychotic Disorders

Locations

Country	Name	City	State
United States	Harding Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas Breitborde

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Palmier-Claus JE, Ainsworth J, Machin M, Barrowclough C, Dunn G, Barkus E, Rogers A, Wykes T, Kapur S, Buchan I, Salter E, Lewis SW. The feasibility and validity of ambulatory self-report of psychotic symptoms using a smartphone software application. BMC Psychiatry. 2012 Oct 17;12:172. doi: 10.1186/1471-244X-12-172. — View Citation

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Wilkinson, G.S. and G.J. Robertson, Wide Range Achievement Test (WRAT4)2006, Lutz, FL: PAR, Inc

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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