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SchizophreniaNCT00291200

Enhancing the Prospective Prediction of Psychosis

An observational study of Schizophrenia and Psychotic Disorders, run by Yale University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 12 to 35 years
Conditions the study is for
Schizophrenia, Psychotic Disorders
How many people
268 participants
Where
3 sitesin 2 countries
Study dates
Aug 2003to Feb 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites
  • PRIME Clinic

    Chapel Hill, North Carolina, 27599

  • Prevention through Risk Identification Management and Education (PRIME) Clinic

    New Haven, Connecticut, 06519

Other trials in United States

Canada1 site
  • PRIME Clinic

    Toronto, Ontario

Other trials in Canada

About this study

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.

Keywords
Psychosis, Basic Symptoms
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00291200
Study groupRoleWhat they receive
1Participants with basic symptoms of psychosis
2Control participants

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startAug 2003
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291200
Sponsor's protocol ID
MH61282
Other IDs
5U01MH066160, DATR AD-P
Status last verified
Jun 2014
First submitted
10 Feb 2006
Last updated
10 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Psychotic Disorders, run by Yale University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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