Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study

NCT02321943 | Completed

• 1 other identifier: 150281
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Disorders With Psychotic Features; Affective Disorders, Psychotic; Self Concept

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE

  6 year

Secondary Outcomes (1)

• Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)

  6 year

Other Outcomes (5)

• Change From Baseline in Positive and negative syndrome

  6 year

• Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS)

  6 year

• Change from Baseline for Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)

  6 year

Study Arms (1)

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".

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Patients with brain injury,
• Patients with on going substance use,
• Unable to provide informed consent statement.
• Not able to be interviewed.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Sykehuset Innlandet HF

Brumunddal, 2380, Norway

Location

Related Publications (5)

• 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.

  PMID: 25458477 BACKGROUND

• 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.

  PMID: 24378241 BACKGROUND

• 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.

  PMID: 22759943 BACKGROUND

• 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.

  PMID: 22137461 BACKGROUND

• 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.

  PMID: 21871617 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests including cardiovascular risk factors and immunological parameters (cytokines).

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

NO (1)