- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02321943
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
April 26, 2017 updated by: Sykehuset Innlandet HF
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 Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brumunddal, Norway, 2380
- Sykehuset Innlandet HF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with brain injury,
- Patients with on going substance use,
- Unable to provide informed consent statement.
- Not able to be interviewed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE
Time Frame: 6 year
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6 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)
Time Frame: 6 year
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6 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Positive and negative syndrome
Time Frame: 6 year
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Positive and Negative Syndrome Scale (PANSS) Total Score and Subscales of PANSS
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6 year
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Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS)
Time Frame: 6 year
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6 year
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Change from Baseline for Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)
Time Frame: 6 year
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6 year
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Change from Baseline for neurocognitive tests battery
Time Frame: 6 year
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6 year
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Change from Baseline for Global Assessment of Functioning - split Version(GAF)
Time Frame: 6 year
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6 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Haug 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.
- Haug 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.
- Haug 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.
- Haug 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
December 17, 2014
First Submitted That Met QC Criteria
December 19, 2014
First Posted (Estimate)
December 22, 2014
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150281
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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