Understanding Hallucinations (Part I)

• Conditions: No Hallucinations; Hallucinations

• Registration Number: NCT01907568
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Parnassia Bavo Groep; 🇳🇱 Den Haag, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands