Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects

Conditions
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Anxiety State

Intervention / Treatment
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* Drug: RisperiDONE 0.5 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Responder<br>The 2 arms will be created according to the early response to risperidone (responder vs. non responder) | Drug: RisperiDONE 0.5 MG<br>* To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.<br>|
| Other: Non responder<br>The 2 arms will be created according to the early response to risperidone (responder vs. non responder) | Drug: RisperiDONE 0.5 MG<br>* To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs) | changes between baseline and day 1 and between baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of anxiety | score in the Post-trauma CheckList 5 | changes between baseline and day 1 and between baseline and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risperidone, anxiety, cognition, stress