Understanding Hallucinations (Part I)

Hallucinations Clinical Trial

— UH-1  

Official title:

Understanding Hallucinations (Part I) - Phenomenology and Cognition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01907568
• Other study ID #: UH-1
• Secondary ID: NL42959.041.13
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2013
• Last updated: October 25, 2016
• Start date: June 2013
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: UMC Utrecht
• Contact: Mascha M.J. Linszen, MD
• Phone: +31887557468
• Email: m.m.j.linszen[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hallucinations
• No Hallucinations

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam
Netherlands	Parnassia Bavo Groep	Den Haag
Netherlands	UMC Groningen	Groningen
Netherlands	UMC Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Free University Medical Center, Parnassia Groep, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Three years	No
Secondary	The internal consistency, test-retest reliability, inter-rater reliability, criterion validity and construct validity of a newly developed questionnaire.		Two years	No
Secondary	The difference in scores on cognitive assessment between participant groups with and without psychotic symptoms.		Three years	No