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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UMC Utrecht

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Medical Center Groningen
Free University Medical Center
Parnassia Groep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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