Clinical trial NCT03227562: Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
Official title: Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anxiety State
Keywords: risperidone
anxiety
cognition
stress
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2017-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: changes between baseline and day 1 and between baseline and week 12
Secondary outcomes:
measure: Type of anxiety
timeFrame: changes between baseline and day 1 and between baseline and week 12
Other outcomes:
measure: Cognition
timeFrame: changes between baseline and day 1 and between baseline and week 12
Locations:
city: Brétigny-sur-Orge
country: France
facility: Marion Trousselard
state: Not In US/Canada
Study officials:
affiliation: HIA Begin Paris
name: Bertrand Lahutte
role: PRINCIPAL_INVESTIGATOR
References: