Trial Outcomes & Findings for Past Pain Experience and Perception of Experimental Pain (NCT NCT01575912)

Results Overview

pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain.

Recruitment status

COMPLETED

Target enrollment

92 participants

Primary outcome timeframe

one month

Results posted on

2017-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Group of Subjects Presenting Schizophrenia SC subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests	Group of Subjects Presenting Major Depression MD subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests	Group of Subjects Without Psychiatric Troubles C subjects without any psychiatric disorder and submitted to experimental pain tests
Overall Study STARTED	30	32	30
Overall Study COMPLETED	30	32	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Past Pain Experience and Perception of Experimental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group of Subjects With Schizophrenia SC n=30 Participants subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests	Group of Subjects Presenting Major Depression MD n=32 Participants subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests	Group of Controls Without Psychiatric Disorder n=30 Participants subjects without any psychiatric disorder and submitted to experimental pain tests	Total n=92 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 9.72 • n=93 Participants	44.69 years STANDARD_DEVIATION 10.08 • n=4 Participants	41.53 years STANDARD_DEVIATION 10.27 • n=27 Participants	43.21 years STANDARD_DEVIATION 10.00 • n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	27 Participants n=4 Participants	17 Participants n=27 Participants	51 Participants n=483 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants	41 Participants n=483 Participants
Region of Enrollment France	30 participants n=93 Participants	32 participants n=4 Participants	30 participants n=27 Participants	92 participants n=483 Participants

PRIMARY outcome

Timeframe: one month

Population: analysis per arm group

pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain.

Outcome measures

Outcome measures
Measure	Group of Subjects Presenting Schizophrenia SC n=30 Participants subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests	Group of Subjects With Major Depression MD n=32 Participants subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests	Group of Subjects Without Psychiatric Troubles C n=30 Participants control subjects without any psychiatric disorder
Visual Analog Scale Evaluation for the Pre-fixed Pressure Test	2.8 units on a scale Standard Deviation 3.2	2.1 units on a scale Standard Deviation 1.8	1.2 units on a scale Standard Deviation 1.3

Adverse Events

Group of Subjects With Schizophrenia SC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group of Subjects Presenting Major Depression MD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group of Controls Without Psychiatric Disorder

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

Dr Murielle Girard

Centre Hospitalier Esquirol

Phone: 0033555431028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place