HallucinationsUH-1NCT01907568
Understanding Hallucinations (Part I)
An observational study of Hallucinations and No Hallucinations, run by UMC Utrecht at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallucinations, No Hallucinations
- How many people
- 700 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jun 2013to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Sophie M. Heringa, PhD contact
Netherlands4 sites, 4 recruiting
- Recruiting
VU Medical Center
Amsterdam
Mascha Linszen, MD
Odile van den Heuvel, MD, PhD
- Not yet recruiting
UMC Groningen
Groningen
Anne-Marthe Meppelink, MD
Teus van Laar, MD, PhD
- Recruiting
Parnassia Bavo Groep
The Hague
Karin Slotema, MD, PhD
Karin Slotema, MD, PhD
- Recruiting
UMC Utrecht
Utrecht
Mascha Linszen, MD, +31887557468, m.m.j.linszen@umcutrecht.nl
Sophie Heringa, PhD, +31887557468, s.m.heringa@umcutrecht.nl
About this study
Official title: 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.
- Conditions
- Hallucinations, No Hallucinations
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
Secondary outcomes (2)
The internal consistency, test-retest reliability, inter-rater reliability, criterion validity and construct validity of a newly developed questionnaire.
Measured: Two years
The difference in scores on cognitive assessment between participant groups with and without psychotic symptoms.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HallucinationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Universitair Ziekenhuis Brussel, Parnassia Groep
- Responsible party
- Principal investigator, Iris Sommer, UMC Utrecht
- Investigators
- Iris Sommer, Prof, MD, PhD, Principal investigator, UMC UtrechtTeus van Laar, MD, PhD, Principal investigator, UMC GroningenPhilip Scheltens, Prof, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcKarin Slotema, MD, PhD, Principal investigator, Parnassia Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907568
- Sponsor's protocol ID
- UH-1
- Other IDs
- NL42959.041.13
- Acronym
- UH-1
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Hallucinations (Part I) - Phenomenology and Cognition
- ClinicalTrials.gov ID
- NCT01907568
- Acronym / sponsor ID
- UH-1 / UH-1
- Conditions
- Hallucinations, No Hallucinations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Universitair Ziekenhuis Brussel, Parnassia Groep
- Study start
- Jun 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie M. Heringa, PhD contact
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallucinations and No Hallucinations, run by UMC Utrecht at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mascha M.J. Linszen, MD (+31887557468, m.m.j.linszen@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.