Clinical trial NCT00291200: Enhancing the Prospective Prediction of Psychosis
Official title: Enhancing the Prospective Prediction of Psychosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Psychotic Disorders
Keywords: Psychosis
Basic Symptoms
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-02-13
Enrollment: 268
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Information on the natural history of basic symptoms of psychosis
timeFrame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5
measure: Factors that may affect the improvement or persistence of basic symptoms of psychosis
timeFrame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Prevention through Risk Identification Management and Education (PRIME) Clinic
state: Connecticut
city: Chapel Hill
country: United States
facility: PRIME Clinic
state: North Carolina
city: Toronto
country: Canada
facility: PRIME Clinic
state: Ontario
Study officials:
affiliation: Yale University
name: Scott W. Woods, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Jean Addington, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Diana O. Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: