Schizophreniform,First Episode PsychosisNCT00248027
Tracking Service Use and Outcomes II:First Episode Psychosis and Psychotic Disorders Clinic
An observational study of Schizophreniform,First Episode Psychosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Main Research questions: 1. Who are the patients referred for treatment at the Psychotic Disorders Clinic? 2. What are the outcomes from treatment for first episode psychosis in multiple outcome domains? 3. What hospital resources are used over the early course of the illness? 4. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Schizophreniform,First Episode Psychosis
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jan 2004to not given
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- male or female between ages of 16 to 50 years of age
- capable of providing informed consent
- receiving treatment voluntarily
- experiencing a "first episode of psychosis" defined as the first episode of illness and where the subject,at presentation,meets DSM-IV criteria for one of the following diagnoses:schizophrenia,schizophreniform disorder,schizoaffective disorder,brief psychotic disorder,delusional disorder,and psychosis NOS
Who cannot join
- primary diagnosis of mood disorder
- diagnosis of substance-induced psychosis
- diagnosis of psychosis due to a general medical condition
- diagnosis of mental retardation
- diagnosis of developmental disorder
- has received antipsychotic treatment for greater than 1 month
- has received treatment for an earlier episode of psychosis from which there has been a remission of symptoms for greater than 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cleghorn Program-Early Intervention in Psychosis.St Joseph's Healthcare Hamilton/Hamilton Health Sciences
Hamilton, Ontario, L8N 1Y2
About this study
Main Research questions:
- Who are the patients referred for treatment at the Psychotic Disorders Clinic?
- What are the outcomes from treatment for first episode psychosis in multiple outcome domains?
- What hospital resources are used over the early course of the illness?
- How satisfied are patients and family with the treatment and services they received? This is an important study that will help us evaluate the service and treatment offered by the Psychotic Disorders Clinic's specialized early intervention program,which helps young people experiencing early stages of psychotic illness.A growing body of evidence suggests that intervening earlier in the course of the illness with specialized and complimentary pharmacological and psychosocial treatment may be associated with improved outcomes.
Read the detailed description
The project is primarily a descriptive study of individuals experiencing their first episode of psychosis presenting at the Psychotic Disorders Clinic/Early Intervention Program.
The objectives of the study are:
- Track multi-dimensional outcomes within the program
- Track service use
- Compare outcomes for this early intervention program with outcomes noted in published follow up studies
- Evaluate effectiveness of the Psychotic Disorders Clinic in improving outcomes for persons experiencing their first episode of psychosis
- Conditions
- Schizophreniform,First Episode Psychosis
- Keywords
- early intervention,program evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophreniform,First Episode PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Suzanne Archie, MD,FRCP(C), Principal investigator, Assistant Professor Dept of Psychiatry and Behavioural Neurosciences McMaster University.Active Medical Staff Hamilton Health Sciences.Clinical Director of Cleghorn Early Intervention in Psychosis Program and Psychotic Disorders Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248027
- Sponsor's protocol ID
- REB #04-203
- Status last verified
- Sep 2006
- First submitted
- 1 Nov 2005
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Service Use and Outcomes II:First Episode Psychosis and Psychotic Disorders Clinic
- ClinicalTrials.gov ID
- NCT00248027
- Acronym / sponsor ID
- REB #04-203
- Conditions
- Schizophreniform,First Episode Psychosis
- Keywords
- early intervention,program evaluation
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 3 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main Research questions:
- Who are the patients referred for treatment at the Psychotic Disorders Clinic?
- What are the outcomes from treatment for first episode psychosis in multiple outcome domains?
- What hospital resources are used over the early course of the illness?
- How satisfied are patients and family with the treatment and services they received? This is an important study that will help us evaluate the service and treatment offered by the Psychotic Disorders Clinic's specialized early intervention program,which helps young people experiencing early stages of psychotic illness.A growing body of evidence suggests that intervening earlier in the course of the illness with specialized and complimentary pharmacological and psychosocial treatment may be associated with improved outcomes.
Detailed description
The project is primarily a descriptive study of individuals experiencing their first episode of psychosis presenting at the Psychotic Disorders Clinic/Early Intervention Program.
The objectives of the study are:
- Track multi-dimensional outcomes within the program
- Track service use
- Compare outcomes for this early intervention program with outcomes noted in published follow up studies
- Evaluate effectiveness of the Psychotic Disorders Clinic in improving outcomes for persons experiencing their first episode of psychosis
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- male or female between ages of 16 to 50 years of age
- capable of providing informed consent
- receiving treatment voluntarily
- experiencing a "first episode of psychosis" defined as the first episode of illness and where the subject,at presentation,meets DSM-IV criteria for one of the following diagnoses:schizophrenia,schizophreniform disorder,schizoaffective disorder,brief psychotic disorder,delusional disorder,and psychosis NOS
Key exclusion criteria (7 listed)
- primary diagnosis of mood disorder
- diagnosis of substance-induced psychosis
- diagnosis of psychosis due to a general medical condition
- diagnosis of mental retardation
- diagnosis of developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Archie, MD,FRCP(C) principal investigator
Assistant Professor Dept of Psychiatry and Behavioural Neurosciences McMaster University.Active Medical Staff Hamilton Health Sciences.Clinical Director of Cleghorn Early Intervention in Psychosis Program and Psychotic Disorders Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophreniform,First Episode Psychosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 was stopped early. Results are not available in the source record.
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.
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 13 Sep 2006.