Clinical trial NCT02321943: Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
Official title: Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia and Disorders With Psychotic Features
Affective Disorders, Psychotic
Self Concept
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2014-12-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE
timeFrame: 6 year
Secondary outcomes:
measure: Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)
timeFrame: 6 year
Other outcomes:
measure: Change From Baseline in Positive and negative syndrome
timeFrame: 6 year
measure: Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS)
timeFrame: 6 year
measure: Change from Baseline for Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)
timeFrame: 6 year
measure: Change from Baseline for neurocognitive tests battery
timeFrame: 6 year
measure: Change from Baseline for Global Assessment of Functioning - split Version(GAF)
timeFrame: 6 year
Locations:
city: Brumunddal
country: Norway
facility: Sykehuset Innlandet HF
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.