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Understanding Hallucinations (Part I) (UH-1)

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ClinicalTrials.gov Identifier: NCT01907568
Recruitment Status : Recruiting
First Posted : July 25, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
University Medical Center Groningen
Free University Medical Center
Parnassia Groep
Information provided by (Responsible Party):
Iris Sommer, 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.

Condition or disease
Hallucinations No Hallucinations

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Understanding Hallucinations (Part I) - Phenomenology and Cognition
Study Start Date : June 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

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



Primary Outcome Measures :
  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. [ Time Frame: Three years ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907568


Contacts
Contact: Mascha M.J. Linszen, MD +31887557468 m.m.j.linszen@umcutrecht.nl
Contact: Sophie M. Heringa, PhD s.m.heringa@umcutrecht.nl

Locations
Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands
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         
Parnassia Bavo Groep Recruiting
Den Haag, Netherlands
Contact: Karin Slotema, MD, PhD         
Principal Investigator: Karin Slotema, MD, PhD         
Sub-Investigator: Joop de Jong, MD, PhD         
UMC Groningen Not yet recruiting
Groningen, Netherlands
Contact: Anne-Marthe Meppelink, MD         
Principal Investigator: Teus van Laar, MD, PhD         
Sub-Investigator: Anne-Marthe Meppelink, MD         
Sub-Investigator: Marouska van Ommen, BSc.         
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Mascha Linszen, MD    +31887557468    m.m.j.linszen@umcutrecht.nl   
Contact: Sophie Heringa, PhD    +31887557468    s.m.heringa@umcutrecht.nl   
Principal Investigator: Iris Sommer, Prof.Dr.         
Sub-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         
Sponsors and Collaborators
UMC Utrecht
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 VU University Medical Center
Principal Investigator: Karin Slotema, MD, PhD Parnassia Groep

Responsible Party: Iris Sommer, Prof.Dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01907568     History of Changes
Other Study ID Numbers: UH-1
NL42959.041.13 ( Other Identifier: Toetsingonline )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hallucinations
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms