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

Schizophrenia and Disorders With Psychotic Features Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321943
• Other study ID #: 150281
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: April 26, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Disorders With Psychotic Features
• Schizophrenia Spectrum and Other Psychotic Disorders
• Self Concept

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet HF	Brumunddal

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Haug E, Lien L, Raballo A, Bratlien U, Oie M, Andreassen OA, Melle I, Møller 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. — View Citation

Haug E, Melle I, Andreassen OA, Raballo A, Bratlien U, Øie M, Lien L, Møller 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. — View Citation

Haug E, Øie M, Andreassen OA, Bratlien U, Nelson B, Aas M, Møller 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. — View Citation

Haug E, Øie M, Andreassen OA, Bratlien U, Raballo A, Nelson B, Møller 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. — View Citation

Haug E, Øie M, Melle I, Andreassen OA, Raballo A, Bratlien U, Lien L, Møller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Positive and negative syndrome	Positive and Negative Syndrome Scale (PANSS) Total Score and Subscales of PANSS	6 year
Other	Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS)		6 year
Other	Change from Baseline for Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)		6 year
Other	Change from Baseline for neurocognitive tests battery		6 year
Other	Change from Baseline for Global Assessment of Functioning - split Version(GAF)		6 year
Primary	Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE		6 year
Secondary	Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)		6 year