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Identifying Factors That Affect Basic Symptoms of Psychosis
This study is ongoing, but not recruiting participants.
Study NCT00291200   Information provided by National Institute of Mental Health (NIMH)
First Received: February 10, 2006   Last Updated: October 16, 2008   History of Changes

February 10, 2006
October 16, 2008
August 2003
 
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00291200 on ClinicalTrials.gov Archive Site
 
 
 
Identifying Factors That Affect Basic Symptoms of Psychosis
Enhancing the Prospective Prediction 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.

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.

 
Observational
Case Control, Prospective
  • Schizophrenia
  • Psychotic Disorders
 
  • Participants with basic symptoms of psychosis
  • Control participants
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
360
March 2008
 

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
Both
12 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00291200
Scott W. Woods, MD, Yale School of Medicine
MH61282, DATR AD-P
National Institute of Mental Health (NIMH)
 
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
National Institute of Mental Health (NIMH)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP