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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
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.
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).
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Marion Trousselard
Brétigny-sur-Orge, Not in US/Canada, France
Start Date
September 1, 2017
Primary Completion Date
September 1, 2021
Completion Date
December 1, 2021
Last Updated
August 4, 2022
120
ACTUAL participants
RisperiDONE 0.5 MG
DRUG
Lead Sponsor
Marion Trousselard
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07261410