Status unknownNCT01907568UH-1Updated Oct 26, 2016

Understanding Hallucinations (Part I)

An observational study in Hallucinations and No Hallucinations, sponsored by UMC Utrecht. Status unknown at 4 sites in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by UMC Utrecht · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Cross-sectional
Enrollment: 700
Ages: 18 Years and older
Sex: All

Study 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 studied

Hallucinations
No Hallucinations

Browse trials for

Hallucinations 132

In context

Hallucinations

132 studies on the registry are indexed under Hallucinations; 36 are open to participants now.

This study's planned enrollment of 700 is above the median of 70 across 17 observational studies indexed under Hallucinations.

Browse Hallucinations studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
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:

patients with schizophrenia spectrum disorders
patients with borderline personality disorder (BPD)
patients with hearing impairment
patients with visual loss
patients with Parkinson's disease (PD)
patients with Alzheimer's disease (AD)
patients with Lewy Body dementia (DLB)
patients with post-traumatic stress disorder (PTSD)
patients with delirium
healthy individuals
patients with mood disorder

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

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
Enrollment: 700 participants (estimated)
Patient registry: No

Groups and cohorts

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

What researchers measure

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.
Time frame: Two years
The difference in scores on cognitive assessment between participant groups with and without psychotic symptoms.
Time frame: Three years

Study locations

3 of 4 sites recruiting

VU Medical Center
Amsterdam, Netherlands
- Mascha Linszen, MD · Contact
- Odile van den Heuvel, MD, PhD · Contact
- Philip Scheltens, Prof.Dr. · Principal investigator
- Odile van den Heuvel, MD, PhD · Sub investigator
- Evelien Lemstra, MD, PhD · Sub investigator
- Elizabeth Foncke, MD, PhD · Sub investigator
Recruiting
Parnassia Bavo Groep
Den Haag, Netherlands
- Karin Slotema, MD, PhD · Contact
- Karin Slotema, MD, PhD · Principal investigator
- Joop de Jong, MD, PhD · Sub investigator
Recruiting
UMC Groningen
Groningen, Netherlands
- Anne-Marthe Meppelink, MD · Contact
- Teus van Laar, MD, PhD · Principal investigator
- Anne-Marthe Meppelink, MD · Sub investigator
- Marouska van Ommen, BSc. · Sub investigator
Not yet recruiting
UMC Utrecht
Utrecht, Netherlands
- Mascha Linszen, MD · Contact · m.m.j.linszen@umcutrecht.nl · +31887557468
- Sophie Heringa, PhD · Contact · s.m.heringa@umcutrecht.nl · +31887557468
- Iris Sommer, Prof.Dr. · Principal investigator
- Remko van Lutterveld, PhD · Sub investigator
- Sanne Koops, Msc. · Sub investigator
- Arjen Slooter, MD, PhD · Sub investigator
- Sophie Heringa, PhD · Sub investigator
- Maya Schutte, Msc. · Sub investigator
- Mascha Linszen, MD · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01907568
Lead sponsor: UMC Utrecht
Collaborators: University Medical Center Groningen, Free University Medical Center, Parnassia Groep
Responsible party: Iris Sommer (Prof.Dr., UMC Utrecht) — Principal investigator
First posted: Jul 25, 2013
Start date: Jun 2013
Primary completion: Jan 2017 (estimated)
Completion: Jan 2018 (estimated)
Last update: Oct 26, 2016

Study contacts

Mascha M.J. Linszen, MD

Contact

m.m.j.linszen@umcutrecht.nl

+31887557468

Sophie M. Heringa, PhD

Contact

s.m.heringa@umcutrecht.nl

Iris Sommer, Prof, MD, PhD

principal investigator · UMC Utrecht

Teus van Laar, MD, PhD

principal investigator · UMC Groningen

Philip Scheltens, Prof, MD, PhD

principal investigator · Amsterdam UMC, location VUmc

Karin Slotema, MD, PhD

principal investigator · Parnassia Groep

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hallucinations→

Other studies from this sponsor

UMC Utrecht

Start the discussion