Studies
| Study First Submitted Date | 2020-04-27 |
| Study First Posted Date | 2020-04-30 |
| Last Update Posted Date | 2023-08-02 |
| Start Month Year | November 1, 2023 |
| Primary Completion Month Year | April 3, 2025 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-08-02 |
Detailed Descriptions
| Sequence: | 20659939 |
| 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. |
Facilities
| Sequence: | 199422758 |
| Name | Harding Hospital |
| City | Columbus |
| State | Ohio |
| Zip | 43210 |
| Country | United States |
Facility Contacts
| Sequence: | 28027032 |
| Facility Id | 199422758 |
| Contact Type | primary |
| Name | Nicholas Breitborde, PhD |
| nicholas.breitborde@osumc.edu | |
| Phone | 614-685-6052 |
Conditions
| Sequence: | 52010675 | Sequence: | 52010676 |
| Name | Psychosis | Name | First Episode Psychosis |
| Downcase Name | psychosis | Downcase Name | first episode psychosis |
Id Information
| Sequence: | 40033171 |
| Id Source | org_study_id |
| Id Value | 2020H0066 |
Countries
| Sequence: | 42429289 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55416395 | Sequence: | 55416396 |
| Title | First-Episode Psychosis | Title | Healthy |
| Description | Twenty individuals with FEP will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL). | Description | 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). |
Design Outcomes
| Sequence: | 176817864 | Sequence: | 176817865 | Sequence: | 176817866 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Differences in mean temperature and diurnal temperature variation | Measure | Differences in mean temperature and temperature variation during periods of rest and activity | Measure | Association of core body temperature and ratings of psychotic symptomatology in FEP |
| Time Frame | 24 hour intervals | Time Frame | 24 hour intervals | Time Frame | 24 hour intervals |
| Description | Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis. | Description | Differences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis. | Description | Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis. |
Browse Conditions
| Sequence: | 192851176 | Sequence: | 192851177 | Sequence: | 192851178 |
| Mesh Term | Psychotic Disorders | Mesh Term | Mental Disorders | Mesh Term | Schizophrenia Spectrum and Other Psychotic Disorders |
| Downcase Mesh Term | psychotic disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | schizophrenia spectrum and other psychotic disorders |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48169421 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Nicholas Breitborde |
Central Contacts
| Sequence: | 11972918 |
| Contact Type | primary |
| Name | Nicholas Breitborde, PhD |
| Phone | (614) 685-6052 |
| nicholas.breitborde@osumc.edu | |
| Role | Contact |
Eligibilities
| Sequence: | 30671313 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 35 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Population | 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. |
| Criteria | 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 |
| Adult | True |
| Child | False |
| Older Adult | False |
Calculated Values
| Sequence: | 254297502 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 35 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 3 |
Designs
| Sequence: | 30418085 |
| Observational Model | Case-Control |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28784598 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Nicholas Breitborde |
| Title | Associate Professor |
| Affiliation | Ohio State University |
Study References
| Sequence: | 51898951 | Sequence: | 51898971 | Sequence: | 51898950 | Sequence: | 51898952 | Sequence: | 51898953 | Sequence: | 51898954 | Sequence: | 51898955 | Sequence: | 51898956 | Sequence: | 51898957 | Sequence: | 51898958 | Sequence: | 51898959 | Sequence: | 51898960 | Sequence: | 51898961 | Sequence: | 51898962 | Sequence: | 51898963 | Sequence: | 51898964 | Sequence: | 51898965 | Sequence: | 51898966 | Sequence: | 51898967 | Sequence: | 51898968 | Sequence: | 51898969 | Sequence: | 51898970 | Sequence: | 51898972 | Sequence: | 51898973 | Sequence: | 51898974 |
| Pmid | 2927577 | Pmid | 19011447 | Pmid | 3251495 | Pmid | 8398951 | Pmid | 21978215 | Pmid | 20438740 | Pmid | 11564466 | Pmid | 17996259 | Pmid | 26629908 | Pmid | 15469188 | Pmid | 8370796 | Pmid | 19493658 | Pmid | 22488144 | Pmid | 23075387 | Pmid | 10867307 | Pmid | 17588237 | Pmid | 21671239 | Pmid | 26794588 | Pmid | 2748771 | Pmid | 3616518 | ||||||||||
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