Understanding Hallucinations (Part I)

NCT01907568 | Unknown DMC

• 2 other identifiers: UH-1NL42959.041.13
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 4

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.

Conditions

Hallucinations; No Hallucinations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (11)

Patients with schizophrenia

With and without hallucinations

Patients with borderline personality disorder

With and without hallucinations

Patients with hearing impairment

With and without hallucinations

Patients with visual loss

With and without hallucinations

Patients with Parkinson's Disease

With and without hallucinations

Patients with Alzheimer's Disease

With and without hallucinations

Patients with dementia with Lewy Bodies

With and without hallucinations

Patients with Posttraumatic Stress Disorder

With and without hallucinations

Patients with delirium

With and without hallucinations

Healthy participants

With and without hallucinations

Patients with mood disorder

With and without hallucinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include subjects of each of the following diagnostic groups, both with and without psychotic symptoms: 1. patients with schizophrenia spectrum disorders 2. patients with borderline personality disorder (BPD) 3. patients with hearing impairment 4. patients with visual loss 5. patients with Parkinson's disease (PD) 6. patients with Alzheimer's disease (AD) 7. patients with Lewy Body dementia (DLB) 8. patients with post-traumatic stress disorder (PTSD) 9. patients with delirium 10. healthy individuals 11. patients with mood disorder

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• University Medical Center Groningen: collaborator
• Free University Medical Center: collaborator
• Parnassia Groep: collaborator

Study Sites (4)

VU Medical Center

Amsterdam, Netherlands

RECRUITING

UMC Groningen

Groningen, Netherlands

NOT YET RECRUITING

Parnassia Bavo Groep

The Hague, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris Sommer, Prof, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Teus van Laar, MD, PhD

  UMC Groningen

  PRINCIPAL INVESTIGATOR

• Philip Scheltens, Prof, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Karin Slotema, MD, PhD

  Parnassia Groep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mascha M.J. Linszen, MD

CONTACT

+31887557468; m.m.j.linszen@umcutrecht.nl

Sophie M. Heringa, PhD

CONTACT

s.m.heringa@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 25, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

NL (4)