Schizophrenia and Disorders With Psychotic FeaturesNCT02321943
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
An observational study of Schizophrenia and Disorders With Psychotic Features and Affective Disorders, Psychotic, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Affective Disorders, Psychotic, Self Concept
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Dec 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients reffered to their first adequate treatment for broadly defines psychotic disorders (inkluding both schizophrenia - and bipolar Spectrum disorders) in Oppland and Hedmark counties in Norway, in 2008 - 2009 participated the base-line part of the study(E. Haug, 2012).
Who may be able to join
- Patients who participated and completed base-line part of the study,
- Patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use.
Who cannot join
- Patients with brain injury,
- Patients with on going substance use,
- Unable to provide informed consent statement.
- Not able to be interviewed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. The overall aim is to expand our knowledge about the role of SDs in psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current study is a seven year follow-up of this representative cohort, with baseline measures of SDs and a comprehensive clinical and neurocognitive assessment battery.
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Affective Disorders, Psychotic, Self Concept
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Affective Disorders, Psychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follow-Up Group | An earlier investigated cohort with first episode psychosis patients from two Norwegian counties. Being between 18 - 65 years old and being consecutive in- or outpatient referred to first adequate treatment for a DSM-IV diagnosis of schizophrenia, bipolar disorder, or "other psychosis". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE
Measured: 6 year
Secondary outcomes (1)
Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)
Measured: 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321943
- Sponsor's protocol ID
- 150281
- Status last verified
- Apr 2017
- First submitted
- 17 Dec 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haug E, Oie M, Andreassen OA, Bratlien U, Nelson B, Aas M, Moller P, Melle I. Anomalous self-experience and childhood trauma in first-episode schizophrenia. Compr Psychiatry. 2015 Jan;56:35-41. doi: 10.1016/j.comppsych.2014.10.005. Epub 2014 Oct 16.
PubMed 25458477Haug E, Oie M, Andreassen OA, Bratlien U, Raballo A, Nelson B, Moller P, Melle I. Anomalous self-experiences contribute independently to social dysfunction in the early phases of schizophrenia and psychotic bipolar disorder. Compr Psychiatry. 2014 Apr;55(3):475-82. doi: 10.1016/j.comppsych.2013.11.010. Epub 2013 Nov 28.
PubMed 24378241Haug E, Lien L, Raballo A, Bratlien U, Oie M, Andreassen OA, Melle I, Moller P. Selective aggregation of self-disorders in first-treatment DSM-IV schizophrenia spectrum disorders. J Nerv Ment Dis. 2012 Jul;200(7):632-6. doi: 10.1097/NMD.0b013e31825bfd6f.
PubMed 22759943Haug E, Oie M, Melle I, Andreassen OA, Raballo A, Bratlien U, Lien L, Moller P. The association between self-disorders and neurocognitive dysfunction in schizophrenia. Schizophr Res. 2012 Mar;135(1-3):79-83. doi: 10.1016/j.schres.2011.11.015. Epub 2011 Dec 3.
PubMed 22137461Haug E, Melle I, Andreassen OA, Raballo A, Bratlien U, Oie M, Lien L, Moller P. The association between anomalous self-experience and suicidality in first-episode schizophrenia seems mediated by depression. Compr Psychiatry. 2012 Jul;53(5):456-60. doi: 10.1016/j.comppsych.2011.07.005. Epub 2011 Aug 25.
PubMed 21871617
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT02321943
- Acronym / sponsor ID
- 150281
- Conditions
- Schizophrenia and Disorders With Psychotic Features, Affective Disorders, Psychotic, Self Concept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Dec 2014 (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.
The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. The overall aim is to expand our knowledge about the role of SDs in psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current study is a seven year follow-up of this representative cohort, with baseline measures of SDs and a comprehensive clinical and neurocognitive assessment battery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-Up Group | – | –An earlier investigated cohort with first episode psychosis patients from two Norwegian counties. Being between 18 - 65 years old and being consecutive in- or outpatient referred to first adequate treatment for a DSM-IV diagnosis of schizophrenia, bipolar disorder, or "other psychosis". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reffered to their first adequate treatment for broadly defines psychotic disorders (inkluding both schizophrenia - and bipolar Spectrum disorders) in Oppland and Hedmark counties in Norway, in 2008 - 2009 participated the base-line part of the study(E. Haug, 2012).
Key inclusion criteria (2 listed)
- Patients who participated and completed base-line part of the study,
- Patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use.
Key exclusion criteria (4 listed)
- Patients with brain injury,
- Patients with on going substance use,
- Unable to provide informed consent statement.
- Not able to be interviewed.
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
Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE
Time frame: 6 year
1 secondary outcome
Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)
Time frame: 6 year
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 27 Apr 2017.
- Background: PubMed 25458477Haug E, Oie M, Andreassen OA, Bratlien U, Nelson B, Aas M, Moller P, Melle I. Anomalous self-experience and childhood trauma in first-episode schizophrenia. Compr Psychiatry. 2015 Jan;56:35-41. doi: 10.1016/j.comppsych.2014.10.005. Epub 2014 Oct 16.
- Background: PubMed 24378241Haug E, Oie M, Andreassen OA, Bratlien U, Raballo A, Nelson B, Moller P, Melle I. Anomalous self-experiences contribute independently to social dysfunction in the early phases of schizophrenia and psychotic bipolar disorder. Compr Psychiatry. 2014 Apr;55(3):475-82. doi: 10.1016/j.comppsych.2013.11.010. Epub 2013 Nov 28.
- Background: PubMed 22759943Haug E, Lien L, Raballo A, Bratlien U, Oie M, Andreassen OA, Melle I, Moller P. Selective aggregation of self-disorders in first-treatment DSM-IV schizophrenia spectrum disorders. J Nerv Ment Dis. 2012 Jul;200(7):632-6. doi: 10.1097/NMD.0b013e31825bfd6f.
- Background: PubMed 22137461Haug E, Oie M, Melle I, Andreassen OA, Raballo A, Bratlien U, Lien L, Moller P. The association between self-disorders and neurocognitive dysfunction in schizophrenia. Schizophr Res. 2012 Mar;135(1-3):79-83. doi: 10.1016/j.schres.2011.11.015. Epub 2011 Dec 3.
- Background: PubMed 21871617Haug E, Melle I, Andreassen OA, Raballo A, Bratlien U, Oie M, Lien L, Moller P. The association between anomalous self-experience and suicidality in first-episode schizophrenia seems mediated by depression. Compr Psychiatry. 2012 Jul;53(5):456-60. doi: 10.1016/j.comppsych.2011.07.005. Epub 2011 Aug 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorders, Psychotic, run by Sykehuset Innlandet HF 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 4 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 27 Apr 2017. 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?
Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE (time frame: 6 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321943, which also lists 5 linked publications.
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 27 Apr 2017.