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

Phase 3

Terminated

• Conditions: Anxiety State
• Interventions: Drug: RisperiDONE 0.5 MG

• Registration Number: NCT03227562
• Lead Sponsor: Marion Trousselard

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).

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Study Start: 2017-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non responder	RisperiDONE 0.5 MG	The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
Responder	RisperiDONE 0.5 MG	The 2 arms will be created according to the early response to risperidone (responder vs. non responder)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Type of anxiety	changes between baseline and day 1 and between baseline and week 12	score in the Post-trauma CheckList 5

Trial Locations

Locations (1)

Marion Trousselard; 🇫🇷 Brétigny-sur-Orge, Not In US/Canada, France