SchizophreniaNCT01594528
Behavior During Experimentally Induced Pain
A study testing pain tests in people with Schizophrenia and Major Depression, run by Centre Hospitalier Esquirol at 1 site in France.
Trial summary
Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Major Depression
- What is being tested?
- pain tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the DSM-IV-TR criteria.
- control subjects : without known psychiatric history.
- age between 18 and 60.
Who cannot join
- absence of consent, hospitalization under constraint, absence of health insurance.
- inability to answer the questionnaires
- pregnancy
- antalgic or analgesic treatment
- allergy to latex
- non stabilized high blood pressure, bad blood coagulation,
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- peripheral neuropathy, nerve lesion, dermatosis at the superior extremities, muscular lesion or pathology at the upper member level
- non treated alcohol dependence
- illegal substance consumption in the past 48 hours
- participation to an other biomedical study during the 2 weeks before inclusion, and until the pain tests, if this study can interfere with the realization of the objectives
Trial locations and contacts
1 site in 1 country.
About this study
Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,…).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.
Read the detailed description
The objective is to search for behavioral non verbal indicators of pain during experimentally induced pain (pressure application, ischemia induction).
Included subjects are subjected to experimental pain tests : pressure application (160 kPa) with an algometer to determine the pain with Visual Analogic Scale (VAS), and ischemia induction to determine the time needed to feel pain with an intensity equivalent to 3 with the VAS.
Subjects are filmed during experimentation to identify the corporal mobility signs, facial expression signs and sonorous signs associated to pain stimulation.
Neurophysiological measures complete these observations : surface electromyogram, heart rate measure, blood pressure.
- Conditions
- Schizophrenia, Major Depression
- Being tested
- pain tests
- Keywords
- schizophrenia, major depression, pain, behavior
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Pain, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain testsOther
pain induction with pressure application or ischemia on the arm
| Study group | Role | What they receive |
|---|---|---|
| SC | Experimental | behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia Receives: Other: pain tests |
| controls | Experimental | behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble Receives: Other: pain tests |
| MD | Experimental | behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression Receives: Other: pain tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicators / Minute
number of corporal mobility, facial expression and sound indicators
Measured: during pain tests (average 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Malauzat, Centre Hospitalier Esquirol
- Investigators
- Dominique Malauzat, MD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594528
- Sponsor's protocol ID
- 2012-A00048-35
- Status last verified
- Dec 2018
- First submitted
- 13 Mar 2012
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior During Experimentally Induced Pain
- ClinicalTrials.gov ID
- NCT01594528
- Acronym / sponsor ID
- 2012-A00048-35
- Conditions
- Schizophrenia, Major Depression
- Keywords
- schizophrenia, major depression, pain, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,…).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.
Detailed description
The objective is to search for behavioral non verbal indicators of pain during experimentally induced pain (pressure application, ischemia induction).
Included subjects are subjected to experimental pain tests : pressure application (160 kPa) with an algometer to determine the pain with Visual Analogic Scale (VAS), and ischemia induction to determine the time needed to feel pain with an intensity equivalent to 3 with the VAS.
Subjects are filmed during experimentation to identify the corporal mobility signs, facial expression signs and sonorous signs associated to pain stimulation.
Neurophysiological measures complete these observations : surface electromyogram, heart rate measure, blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SC | Experimental | Other: pain testsbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia |
| controls | Experimental | Other: pain testsbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble |
| MD | Experimental | Other: pain testsbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the DSM-IV-TR criteria.
- control subjects : without known psychiatric history.
- age between 18 and 60.
Key exclusion criteria (10 listed)
- absence of consent, hospitalization under constraint, absence of health insurance.
- inability to answer the questionnaires
- pregnancy
- antalgic or analgesic treatment
- allergy to latex
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 |
|---|---|---|
| pain testspain induction with pressure application or ischemia on the arm | Other | MD, SC, controls |
Primary outcome
Indicators / Minute
Time frame: during pain tests (average 1 hour)
number of corporal mobility, facial expression and sound indicators
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dominique Malauzat, MD principal investigator
Centre Hospitalier Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain tests in people with Schizophrenia and Major Depression, run by Centre Hospitalier Esquirol at 1 site 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Indicators / Minute (time frame: during pain tests (average 1 hour)). 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 22 Mar 2019.