CClinicalTrials.gg
CompletedNCT00291200Updated Jun 10, 2014

Enhancing the Prospective Prediction of Psychosis

An observational study in Schizophrenia and Psychotic Disorders, sponsored by Yale University. Completed at 3 sites in 2 countries. Open to participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-06-10.

Sponsored by Yale University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
268
Ages
12 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Schizophrenia
  • Psychotic Disorders

Keywords

  • Psychosis
  • Basic Symptoms
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 268 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population consists of participants who meet the basic symptoms for psychosis and control participants recruited at three sites: the PRIME Clinics at University of North Carolina, Yale University, and the Center for Addiction and Mental Health (CAMH) in Toronto, Canada.

Inclusion criteria

  • Meets modified criteria of prodromal syndromes (COPS) for schizophrenia prodrome or help-seeking control

Exclusion criteria

Exclusion Criteria:

  • History of psychosis
  • Antipsychotic treatment in the month prior to study entry
  • More than 16 weeks of lifetime antipsychotic treatment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
268 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Participants with basic symptoms of psychosis

  • 2

    Control participants

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What researchers measure

Primary outcomes

  1. Information on the natural history of basic symptoms of psychosis

    Time frame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

  2. Factors that may affect the improvement or persistence of basic symptoms of psychosis

    Time frame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

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Study locations

3 sites
  • Prevention through Risk Identification Management and Education (PRIME) Clinic
    New Haven, Connecticut 06519, United States
  • PRIME Clinic
    Chapel Hill, North Carolina 27599, United States
  • PRIME Clinic
    Toronto, Ontario, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00291200
Lead sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Feb 13, 2006
Start date
Aug 2003
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jun 10, 2014

Study contacts

Scott W. Woods, MD
principal investigator · Yale School of Medicine
Jean Addington, PhD
principal investigator · University of Toronto
Diana O. Perkins, MD, MPH
principal investigator · University of North Carolina
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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