Enhancing the Prospective Prediction of Psychosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00291200
First received: February 10, 2006
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition
Schizophrenia
Psychotic Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Enhancing the Prospective Prediction of Psychosis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples for routine laboratory studies


Enrollment: 268
Study Start Date: August 2003
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants with basic symptoms of psychosis
2
Control participants

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

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291200

Locations
United States, Connecticut
Prevention through Risk Identification Management and Education (PRIME) Clinic
New Haven, Connecticut, United States, 06519
United States, North Carolina
PRIME Clinic
Chapel Hill, North Carolina, United States, 27599
Canada, Ontario
PRIME Clinic
Toronto, Ontario, Canada
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Scott W. Woods, MD Yale School of Medicine
Principal Investigator: Jean Addington, PhD University of Toronto
Principal Investigator: Diana O. Perkins, MD, MPH University of North Carolina
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00291200     History of Changes
Other Study ID Numbers: MH61282, 5U01MH066160, DATR AD-P
Study First Received: February 10, 2006
Last Updated: June 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Psychosis
Basic Symptoms

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 26, 2014