Schizophrenia and Disorders With Psychotic FeaturesNCT01196858
Duration of Untreated Psychosis (DUP) and Pathways to Care in Nordland
An observational study of Schizophrenia and Disorders With Psychotic Features and Affective Psychosis, Bipolar, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
During the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. Studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Affective Psychosis, Bipolar, Psychoses
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Sep 2013
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study is a naturalistic cohort study. All patients registrered in a 3 year period with the acute and/or rehabilitation units will be invited to participate. The eight units (acute and rehabilitation) will be able to provide a potential sample size of 150 participants over the 3-year period of the study. We are confident of minimal attrition and assume that we will achieve at least 85% follow up. This means that we can expect to have collected data on approximately 120 people.
Who may be able to join
- Any patient presenting with a possible psychotic illness (including schizophrenia, affective psychosis and drug-related psychosis, but excluding organic psychosis).
- Understands and speaks norwegian
Who cannot join
- Severe learning disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Untreated Psychosis (DUP) and Pathways to Care in Patients With First- and Multiple Episodes of Psychosis in Nordland - a Study of the Components of DUP in a Rural Mental Health System
During the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. Studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate implications such as unnecessary distress for patients and families, and may also compromise potential recovery when treatment is initiated.By understanding how and why substantial delays occur the investigators may be able to better design interventions to facilitate better earlier treatment. The components of DUP can be conceptualised as comprising 3 distinct intervals: help-seeking delay, referral delay and delay in mental health services. In this study the primary aim is to establish the level of DUP in nordland, and explore the components of this variable. Help-seeking delay will be investigated by interviewing patients presenting at the central mental health hospital in Nordland about their psychosis onset and pathways to care. Referral delay will be investigated by a questionnaire about the referral pratices among GPs in Nordland. Delays in mental health services will be investigated by focus group interviews with leaders and professionals at the 7 community mental health centers in Nordland. This knowledge is believed to be crucial for developing services that can reduce DUP and give this patient population earlier access to adequate treatment.
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Affective Psychosis, Bipolar, Psychoses
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar Disorder, Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of untreated psychosis
Nottingham Onset Schedule
Measured: retrospective, lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Knut W. Soergaard, PhD, Principal investigator, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196858
- Sponsor's protocol ID
- 2009/1426(REK)
- Status last verified
- Jan 2014
- First submitted
- 6 Sep 2010
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Untreated Psychosis (DUP) and Pathways to Care in Patients With First- and Multiple Episodes of Psychosis in Nordland - a Study of the Components of DUP in a Rural Mental Health System
- ClinicalTrials.gov ID
- NCT01196858
- Acronym / sponsor ID
- 2009/1426(REK)
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Affective Psychosis, Bipolar, Psychoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Sep 2010 (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.
During the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. Studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate implications such as unnecessary distress for patients and families, and may also compromise potential recovery when treatment is initiated.By understanding how and why substantial delays occur the investigators may be able to better design interventions to facilitate better earlier treatment. The components of DUP can be conceptualised as comprising 3 distinct intervals: help-seeking delay, referral delay and delay in mental health services. In this study the primary aim is to establish the level of DUP in nordland, and explore the components of this variable. Help-seeking delay will be investigated by interviewing patients presenting at the central mental health hospital in Nordland about their psychosis onset and pathways to care. Referral delay will be investigated by a questionnaire about the referral pratices among GPs in Nordland. Delays in mental health services will be investigated by focus group interviews with leaders and professionals at the 7 community mental health centers in Nordland. This knowledge is believed to be crucial for developing services that can reduce DUP and give this patient population earlier access to adequate treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study is a naturalistic cohort study. All patients registrered in a 3 year period with the acute and/or rehabilitation units will be invited to participate. The eight units (acute and rehabilitation) will be able to provide a potential sample size of 150 participants over the 3-year period of the study. We are confident of minimal attrition and assume that we will achieve at least 85% follow up. This means that we can expect to have collected data on approximately 120 people.
Key inclusion criteria (2 listed)
- Any patient presenting with a possible psychotic illness (including schizophrenia, affective psychosis and drug-related psychosis, but excluding organic psychosis).
- Understands and speaks norwegian
Key exclusion criteria (1 listed)
- Severe learning disability
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
Duration of untreated psychosis
Time frame: retrospective, lifetime
Nottingham Onset Schedule
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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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.
Knut W. Soergaard, PhD principal investigator
Nordlandssykehuset HF
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 Schizophrenia and Disorders With Psychotic Features and Affective Psychosis, Bipolar, run by University Hospital of North Norway at 1 site in Norway.
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 2 inclusion and 1 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 7 Jan 2014. 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 Norway. 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?
Duration of untreated psychosis (time frame: retrospective, lifetime). 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 7 Jan 2014.