PsychosisNCT04369677
Thermoregulation Among Individuals With First-episode Psychosis
An observational study of Psychosis and First Episode Psychosis, run by Nicholas Breitborde at 1 site in United States.
Trial summary
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, First Episode Psychosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 3 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.
Read the 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.
- Conditions
- Psychosis, First Episode Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start17 Jan 2017
- Primary completion3 Apr 2025 (estimated)
- Study completion3 Apr 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas Breitborde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Breitborde, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369677
- Sponsor's protocol ID
- 2020H0066
- Status last verified
- Feb 2026
- First submitted
- 27 Apr 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu BY, Cullen CE, Eide CE, Williams CC, Apfeldorf WJ. Antidepressant-induced sweating alleviated by aripiprazole. J Clin Psychopharmacol. 2008 Dec;28(6):710-1. doi: 10.1097/JCP.0b013e31818d6b67. No abstract available.
PubMed 19011447Vybiral S, Jansky L. The role of dopaminergic pathways in thermoregulation in the rabbit. Neuropharmacology. 1989 Jan;28(1):15-20. doi: 10.1016/0028-3908(89)90061-0.
PubMed 2927577Heh CW, Herrera J, DeMet E, Potkin S, Costa J, Sramek J, Hazlett E, Buchsbaum MS. Neuroleptic-induced hypothermia associated with amelioration of psychosis in schizophrenia. Neuropsychopharmacology. 1988 May;1(2):149-56. doi: 10.1016/0893-133x(88)90006-1.
PubMed 3251495Rubinstein G. Schizophrenia, infection and temperature. An animal model for investigating their interrelationships. Schizophr Res. 1993 Aug;10(2):95-102. doi: 10.1016/0920-9964(93)90043-i.
PubMed 8398951Lkhagvasuren B, Nakamura Y, Oka T, Sudo N, Nakamura K. Social defeat stress induces hyperthermia through activation of thermoregulatory sympathetic premotor neurons in the medullary raphe region. Eur J Neurosci. 2011 Nov;34(9):1442-52. doi: 10.1111/j.1460-9568.2011.07863.x. Epub 2011 Oct 6.
PubMed 21978215Hayashida S, Oka T, Mera T, Tsuji S. Repeated social defeat stress induces chronic hyperthermia in rats. Physiol Behav. 2010 Aug 4;101(1):124-31. doi: 10.1016/j.physbeh.2010.04.027. Epub 2010 May 10.
PubMed 20438740Keeney AJ, Hogg S, Marsden CA. Alterations in core body temperature, locomotor activity, and corticosterone following acute and repeated social defeat of male NMRI mice. Physiol Behav. 2001 Sep 1-15;74(1-2):177-84. doi: 10.1016/s0031-9384(01)00541-8.
PubMed 11564466Radonjic NV, Petronijevic ND, Vuckovic SM, Prostran MS, Nesic ZI, Todorovic VR, Paunovic VR. Baseline temperature in an animal model of schizophrenia: long-term effects of perinatal phencyclidine administration. Physiol Behav. 2008 Feb 27;93(3):437-43. doi: 10.1016/j.physbeh.2007.10.003. Epub 2007 Oct 10.
PubMed 17996259Horvath G, Kekesi G, Petrovszki Z, Benedek G. Abnormal Motor Activity and Thermoregulation in a Schizophrenia Rat Model for Translational Science. PLoS One. 2015 Dec 2;10(12):e0143751. doi: 10.1371/journal.pone.0143751. eCollection 2015.
PubMed 26629908Chong TW, Castle DJ. Layer upon layer: thermoregulation in schizophrenia. Schizophr Res. 2004 Aug 1;69(2-3):149-57. doi: 10.1016/s0920-9964(03)00222-6.
PubMed 15469188Arnold VK, Rosenthal TL, Dupont RT, Hilliard D. Redundant clothing: a readily observable marker for schizophrenia in the psychiatric emergency room population. J Behav Ther Exp Psychiatry. 1993 Mar;24(1):45-7. doi: 10.1016/0005-7916(93)90007-j.
PubMed 8370796Shiloh R, Schapir L, Bar-Ziv D, Stryjer R, Konas S, Louis R, Hermesh H, Munitz H, Weizman A, Valevski A. Association between corneal temperature and mental status of treatment-resistant schizophrenia inpatients. Eur Neuropsychopharmacol. 2009 Sep;19(9):654-8. doi: 10.1016/j.euroneuro.2009.04.010. Epub 2009 Jun 2.
PubMed 19493658Mazerolle SM, Ganio MS, Casa DJ, Vingren J, Klau J. Is oral temperature an accurate measurement of deep body temperature? A systematic review. J Athl Train. 2011 Sep-Oct;46(5):566-73. doi: 10.4085/1062-6050-46.5.566.
PubMed 22488144Palmier-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.
PubMed 23075387First, M.B., et al., Structured Clinical Interview for DSM-5-Research Version2015, Arlington, VA: American Psychiatric Association.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoregulation Among Individuals With First-episode Psychosis
- ClinicalTrials.gov ID
- NCT04369677
- Acronym / sponsor ID
- 2020H0066
- Conditions
- Psychosis, First Episode Psychosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nicholas BreitbordeUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 3 Apr 2025 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 19011447Lu BY, Cullen CE, Eide CE, Williams CC, Apfeldorf WJ. Antidepressant-induced sweating alleviated by aripiprazole. J Clin Psychopharmacol. 2008 Dec;28(6):710-1. doi: 10.1097/JCP.0b013e31818d6b67. No abstract available.
- Background: PubMed 2927577Vybiral S, Jansky L. The role of dopaminergic pathways in thermoregulation in the rabbit. Neuropharmacology. 1989 Jan;28(1):15-20. doi: 10.1016/0028-3908(89)90061-0.
- Background: PubMed 3251495Heh CW, Herrera J, DeMet E, Potkin S, Costa J, Sramek J, Hazlett E, Buchsbaum MS. Neuroleptic-induced hypothermia associated with amelioration of psychosis in schizophrenia. Neuropsychopharmacology. 1988 May;1(2):149-56. doi: 10.1016/0893-133x(88)90006-1.
- Background: PubMed 8398951Rubinstein G. Schizophrenia, infection and temperature. An animal model for investigating their interrelationships. Schizophr Res. 1993 Aug;10(2):95-102. doi: 10.1016/0920-9964(93)90043-i.
- Background: PubMed 21978215Lkhagvasuren B, Nakamura Y, Oka T, Sudo N, Nakamura K. Social defeat stress induces hyperthermia through activation of thermoregulatory sympathetic premotor neurons in the medullary raphe region. Eur J Neurosci. 2011 Nov;34(9):1442-52. doi: 10.1111/j.1460-9568.2011.07863.x. Epub 2011 Oct 6.
- Background: PubMed 20438740Hayashida S, Oka T, Mera T, Tsuji S. Repeated social defeat stress induces chronic hyperthermia in rats. Physiol Behav. 2010 Aug 4;101(1):124-31. doi: 10.1016/j.physbeh.2010.04.027. Epub 2010 May 10.
- Background: PubMed 11564466Keeney AJ, Hogg S, Marsden CA. Alterations in core body temperature, locomotor activity, and corticosterone following acute and repeated social defeat of male NMRI mice. Physiol Behav. 2001 Sep 1-15;74(1-2):177-84. doi: 10.1016/s0031-9384(01)00541-8.
- Background: PubMed 17996259Radonjic NV, Petronijevic ND, Vuckovic SM, Prostran MS, Nesic ZI, Todorovic VR, Paunovic VR. Baseline temperature in an animal model of schizophrenia: long-term effects of perinatal phencyclidine administration. Physiol Behav. 2008 Feb 27;93(3):437-43. doi: 10.1016/j.physbeh.2007.10.003. Epub 2007 Oct 10.
- Background: PubMed 26629908Horvath G, Kekesi G, Petrovszki Z, Benedek G. Abnormal Motor Activity and Thermoregulation in a Schizophrenia Rat Model for Translational Science. PLoS One. 2015 Dec 2;10(12):e0143751. doi: 10.1371/journal.pone.0143751. eCollection 2015.
- Background: PubMed 15469188Chong TW, Castle DJ. Layer upon layer: thermoregulation in schizophrenia. Schizophr Res. 2004 Aug 1;69(2-3):149-57. doi: 10.1016/s0920-9964(03)00222-6.
- Background: PubMed 8370796Arnold VK, Rosenthal TL, Dupont RT, Hilliard D. Redundant clothing: a readily observable marker for schizophrenia in the psychiatric emergency room population. J Behav Ther Exp Psychiatry. 1993 Mar;24(1):45-7. doi: 10.1016/0005-7916(93)90007-j.
- Background: PubMed 19493658Shiloh R, Schapir L, Bar-Ziv D, Stryjer R, Konas S, Louis R, Hermesh H, Munitz H, Weizman A, Valevski A. Association between corneal temperature and mental status of treatment-resistant schizophrenia inpatients. Eur Neuropsychopharmacol. 2009 Sep;19(9):654-8. doi: 10.1016/j.euroneuro.2009.04.010. Epub 2009 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and First Episode Psychosis, run by Nicholas Breitborde at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in mean temperature and diurnal temperature variation (time frame: 24 hour intervals). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369677, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.