Anxiety State
Conditions
Keywords
risperidone, anxiety, cognition, stress
Brief summary
Risperidone at low dosage is often used as treatment of acute anxiety symptom. However, patients may be either responder or not. Here we hypothesized that the early response to a low dose of risperidone is predictive to risperidone efficiency. Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone prescription would be proposed to be enrolled in the study. A check-up is made at D0, then the subjects begin the treatment (0.5mg risperidone). The same check-up is carried out on the following day (D1). The subjects fulfil a last check-up 12 week after the beginning of treatment (W12). During the D1-W12, the psychiatrist may changes the treatment.
Detailed description
Risperidone at low dosage is often used as treatment of acute anxiety symptom. However, patients may be either responder or not. Here we hypothesized that the early response to a low dose of risperidone is predictive to risperidone efficiency. Subjects with acute anxiety symptoms (Hospital anxiety depression scale) and risperidone prescription would be proposed to be enrolled in the study. After acceptation, the fulfil questionnaires (MINI, PCL-s-V) then they interacts with test on computers (PVT, 2nBack, Iowa gambling task) and give saliva and receive an actimetric watch (D0). They begin the treatment on the evening (0.5mg risperidone/day). The following day, they come back to hospital and they fulfil the same tests, questionnaires and samples (D1). 12 week after, they come again to hospital to fulfil the same tests, questionnaires and samples (W12). Between D1 and S12, the psychiatrist may change the treatment, adding other treatment or modifying risperidone treatment (increasing dosage up to 2mg/day or removing it).
Interventions
DRUGRisperiDONE 0.5 MG
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
Sponsors
Marion Trousselard
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects are under 0.5mg risperidone (one group). Accordin to their response to treatment (responder vs. non responder) the 2 experimental groups will be created.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* anxiety (score above 11 at anxiety scale of HADs) * To have a prescription for 0.5 mg risperidone/day * To give the consent * To have a social protection * To be adult (18-50 years)
Exclusion criteria
* Psychiatric antecedents * any treatment for mental disease (antidepressant, anxiolytics, etc.) * Ongoing neurological pathologies * Scheduled surgery * addiction * pregancy * known intolerance to risperidone * participation to another biomedical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | changes between baseline and day 1 and between baseline and week 12 | score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of anxiety | changes between baseline and day 1 and between baseline and week 12 | score in the Post-trauma CheckList 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognition | changes between baseline and day 1 and between baseline and week 12 | score in the Iowa Gambling Task |
Countries
France
Outcome results
None listed