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

Phase

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT03227562

2016-000341-31

Ages 18-50
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

September 01, 2017

December 01, 2021

Study Description

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).

Connect with a study center

Marion Trousselard
Brétigny-sur-Orge, Not In US/Canada 91223
France
Site Not Available

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