Trial Outcomes & Findings for Behavior During Experimentally Induced Pain (NCT NCT01594528)
NCT ID: NCT01594528
Last Updated: 2019-03-22
Results Overview
number of corporal mobility, facial expression and sound indicators
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
during pain tests (average 1 hour)
Results posted on
2019-03-22
Participant Flow
Participant milestones
| Measure |
Control
behavior during experimental pain tests for control subjects
pain tests: pain induction with pressure application or ischemia on the arm
|
SChizophrenia
behavior during experimental pain tests for subjects with schizophrenia
pain tests: pain induction with pressure application or ischemia on the arm
|
Major Depression
behavior during experimental pain tests for subjects with major depression pain tests: pain induction with pressure application or ischemia on the arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavior During Experimentally Induced Pain
Baseline characteristics by cohort
| Measure |
Major Depression
n=16 Participants
subjects with major depression
|
Schizophrenia
n=17 Participants
subjects with schizophrenia
|
Control
n=16 Participants
subjects without psychiatric disorders
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
42 years
n=7 Participants
|
40 years
n=5 Participants
|
41 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during pain tests (average 1 hour)number of corporal mobility, facial expression and sound indicators
Outcome measures
| Measure |
Group of Subjects Presenting Schizophrenia SC
n=17 Participants
subjects with diagnosis of schizophrenia according to the DSM-IV-TR and experimentating pain tests: pain induction with pressure application or ischemia on the arm.
and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests
|
Group of Subjects Presenting Major Depression MD
n=16 Participants
subjects presenting a diagnosis of major depression according to the DSM-IV-TR and experimentating pain tests: pain induction with pressure application or ischemia on the arm.
and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests
|
Group of Subjects Without Psychiatric Troubles C
n=16 Participants
control subjects without any psychiatric disorder and experimentating the same pain tests as the other groups: pain induction with pressure application or ischemia on the arm.
and observation of the behavior as defined with facial, corporal and vocal indicators during experimental pain tests
|
|---|---|---|---|
|
Indicators / Minute
vocal indicators
|
1.925 indicators/minute
Interval 0.0 to 2.4
|
0.23 indicators/minute
Interval 0.0 to 4.23
|
0.4 indicators/minute
Interval 0.0 to 1.15
|
|
Indicators / Minute
body indicators
|
0.45 indicators/minute
Interval 0.0 to 1.6
|
0.59 indicators/minute
Interval 0.0 to 2.1
|
0.55 indicators/minute
Interval 0.0 to 2.7
|
|
Indicators / Minute
facial indicators
|
0.25 indicators/minute
Interval 0.0 to 1.5
|
0.4975 indicators/minute
Interval 0.1 to 3.95
|
0.45 indicators/minute
Interval 0.1 to 4.25
|
Adverse Events
Diagnosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place