Understanding Hallucinations (Part I) (UH-1)

October 25, 2016 updated by: Iris Sommer, UMC Utrecht

Understanding Hallucinations (Part I) - Phenomenology and Cognition

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Three years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

University Medical Center Groningen
Free University Medical Center
Parnassia Groep

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH-1
  • NL42959.041.13 (Other Identifier: Toetsingonline)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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