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Clinical Trials/NCT01907568
NCT01907568
Unknown
Not Applicable

Understanding Hallucinations (Part I) - Phenomenology and Cognition

UMC Utrecht4 sites in 1 country700 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallucinations
Sponsor
UMC Utrecht
Enrollment
700
Locations
4
Primary Endpoint
The number of clusters of patients with shared symptom profiles as determined by latent class analysis, and the difference in scores on cognitive assessment between these identified clusters.
Last Updated
9 years ago

Overview

Brief Summary

Psychotic symptoms (hallucinations and delusions) are present in several psychiatric and neurological disorders as well as in the general population. Effective treatment strategies for these symptoms in all patients are lacking and treatment-response can presently not be predicted. To date, the exact pathophysiological mechanism of these symptoms remains unknown. By investigating (subtypes) of hallucinations and delusions in all populations, a common pathway may be found, leading to more effective treatment options. Alternatively, different subtypes may be associated with different pathophysiological mechanisms.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iris Sommer

Prof.Dr.

UMC Utrecht

Eligibility Criteria

Inclusion Criteria

  • age \> 18 years
  • mentally competent
  • in case of delirium: family member able to give informed consent
  • Individuals with hallucinations will have to experience at least one episode of hallucinations over the last month.
  • Individuals without hallucinations: no current hallucinations and a history of maximum 1 episode of hallucinations with a maximum duration of 1 week, at least two years ago.

Exclusion Criteria

  • Age \<18)
  • Participants that cannot read, speak or understand Dutch
  • For all included diagnostic groups except delirium: Mentally incompetent individuals who are not capable to provide informed consent, as determined by their treating physician.

Outcomes

Primary Outcomes

The number of clusters of patients with shared symptom profiles as determined by latent class analysis, and the difference in scores on cognitive assessment between these identified clusters.

Time Frame: Three years

Secondary Outcomes

  • The internal consistency, test-retest reliability, inter-rater reliability, criterion validity and construct validity of a newly developed questionnaire.(Two years)
  • The difference in scores on cognitive assessment between participant groups with and without psychotic symptoms.(Three years)

Study Sites (4)

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