Enhancing the Prospective Prediction of Psychosis

NCT ID: NCT00291200

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 268 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2009-02-28

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.

Conditions

Schizophrenia; Psychotic Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Participants with basic symptoms of psychosis

No interventions assigned to this group

2

Control participants

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott W. Woods, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Jean Addington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Diana O. Perkins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Prevention through Risk Identification Management and Education (PRIME) Clinic

New Haven, Connecticut, United States

PRIME Clinic

Chapel Hill, North Carolina, United States

PRIME Clinic

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

5U01MH066160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR AD-P

Identifier Type: -

Identifier Source: secondary_id

MH61282

Identifier Type: -

Identifier Source: org_study_id