Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291200
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2006-02-10
Brief Title:
Enhancing the Prospective Prediction of Psychosis
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Enhancing the Prospective Prediction of Psychosis
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will gather information on the natural history of the basic symptoms of psychosis to identify factors that may affect the improvement or persistence of the symptoms
Detailed Description:
Psychosis is a serious mental condition in which a person momentarily loses contact with reality People in a state of psychosis may experience hallucinations or delusional beliefs that make day-to-day functioning difficult During the early development of psychosis people undergo an initial change in mood thinking or behavior that may include making mistakes about smells sounds or sights becoming easily distracted and developing suspicions of others These basic symptoms can be early warning signs of a brain disorder including anxiety disorder depression or psychotic disorder Basic symptoms may be due to a number of factors including a reaction to stress or drugs or just a part of normal adolescence To identify psychosis early and accurately more information is needed on the initial stages biological markers and progression of psychosis This study will gather information on the natural history of the basic symptoms of psychosis to identify factors that may affect the improvement or persistence of the symptoms
Participation in this study will last up to 5 years The initial screening visit will be used to determine whether a participant is eligible for the group displaying basic symptoms or the control group Initial screening will include giving a blood sample for routine lab tests a physical exam a drug test and questions about medical history and symptoms All participants will then partake in baseline evaluations which involve assessments concerning concentration problem solving memory social skills and ability to identify smells Participants will also respond to questions about symptoms school and social functioning stressful situations and family history of illnesses The participants who meet the criteria for basic symptoms will attend monthly 1-hour follow-up visits for the first year of the study During these visits participants will be asked about the status of their basic symptoms and use of medications For the second year of the study follow-up visits will occur every 2 months and for the third fourth and fifth years of the study visits will be every 3 months Repeat baseline assessments will occur every 6 months with each assessment visit lasting about 5 hours All participants will undergo endpoint evaluations that follow the same format as most baseline assessments Participants who develop a psychotic disorder during the study will attend an additional follow-up visit 6 months after the endpoint evaluation to confirm diagnosis Participants who decide that they no longer wish to attend regular study visits may be asked to participate in follow-up telephone interviews about their basic symptoms every 6 months
Participation in this study will last up to 5 years The initial screening visit will be used to determine whether a participant is eligible for the group displaying basic symptoms or the control group Initial screening will include giving a blood sample for routine lab tests a physical exam a drug test and questions about medical history and symptoms All participants will then partake in baseline evaluations which involve assessments concerning concentration problem solving memory social skills and ability to identify smells Participants will also respond to questions about symptoms school and social functioning stressful situations and family history of illnesses The participants who meet the criteria for basic symptoms will attend monthly 1-hour follow-up visits for the first year of the study During these visits participants will be asked about the status of their basic symptoms and use of medications For the second year of the study follow-up visits will occur every 2 months and for the third fourth and fifth years of the study visits will be every 3 months Repeat baseline assessments will occur every 6 months with each assessment visit lasting about 5 hours All participants will undergo endpoint evaluations that follow the same format as most baseline assessments Participants who develop a psychotic disorder during the study will attend an additional follow-up visit 6 months after the endpoint evaluation to confirm diagnosis Participants who decide that they no longer wish to attend regular study visits may be asked to participate in follow-up telephone interviews about their basic symptoms every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR AD-P | US NIH GrantContract | None | httpsreporternihgovquickSearch5U01MH066160 |
| 5U01MH066160 | NIH | None | None |