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Completed

NCT Number: NCT02321943

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Innlandet HF

Brumunddal, 2380, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 year

Secondary outcomes

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

    Time frame: 6 year

Other outcomes

  1. Change From Baseline in Positive and negative syndrome

    Time frame: 6 year

    Positive and Negative Syndrome Scale (PANSS) Total Score and Subscales of PANSS

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

    Time frame: 6 year

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

    Time frame: 6 year

  4. Change from Baseline for neurocognitive tests battery

    Time frame: 6 year

  5. Change from Baseline for Global Assessment of Functioning - split Version(GAF)

    Time frame: 6 year

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • Oslo University Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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