PainNCT01244542
Pain and Schizophrenia
A study testing unpleasant stimuli in people with Pain and Schizophrenia, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial summary
The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Schizophrenia
- What is being tested?
- unpleasant stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 5 sitesFrance
- Study dates
- Aug 2011to Jan 2015
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
- 18-55 years old
Who cannot join
- Past history affecting CNS
- Intake of psychotropic drugs, except for patients
- Metabolic disorder affecting sensory processing (diabetes)
- Intake of benzodiazepines
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
Besançon, 25030
Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
Erstein, 67152
Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67 091
Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
Strasbourg, 67091
Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.
- Conditions
- Pain, Schizophrenia
- Being tested
- unpleasant stimuli
- Keywords
- Schizophrenia, DSM IV criteria, Pain insensitivity, Painful perception, Opioid receptors
- Medical subject headings
- Pain, Schizophrenia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unpleasant stimuliOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Experimental | Not described Receives: Other: unpleasant stimuli |
| Healthy controls | Active comparator | controls matched with patients on age, sex and education level Receives: Other: unpleasant stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unpleasant stimuli
acute electrical stimulation
Measured: during experimental session
Unpleasant stimuli
emotional pictures
Measured: during experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startAug 2011
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Giersch, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244542
- Sponsor's protocol ID
- 4706
- Status last verified
- Sep 2017
- First submitted
- 17 Nov 2010
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Schizophrenia
- ClinicalTrials.gov ID
- NCT01244542
- Acronym / sponsor ID
- 4706
- Conditions
- Pain, Schizophrenia
- Keywords
- Schizophrenia, DSM IV criteria, Pain insensitivity, Painful perception, Opioid receptors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Nov 2010 (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.
The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | Other: unpleasant stimuli |
| Healthy controls | Active comparator | Other: unpleasant stimulicontrols matched with patients on age, sex and education level |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
- 18-55 years old
Key exclusion criteria (4 listed)
- Past history affecting CNS
- Intake of psychotropic drugs, except for patients
- Metabolic disorder affecting sensory processing (diabetes)
- Intake of benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unpleasant stimuli | Other | Healthy controls, Patients with schizophrenia |
Primary outcome
Unpleasant stimuli
Time frame: during experimental session
acute electrical stimulation
Unpleasant stimuli
Time frame: during experimental session
emotional pictures
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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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.
Anne Giersch, MD study director
University Hospital, Strasbourg, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unpleasant stimuli in people with Pain and Schizophrenia, run by University Hospital, Strasbourg, France at 5 sites in France.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unpleasant stimuli (time frame: during experimental session). The study lists 2 primary outcomes in all. 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 5 Oct 2017.