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

NCT ID: NCT03227562

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-12-01

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).

Conditions

Anxiety State

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Responder

The 2 arms will be created according to the early response to risperidone (responder vs. non responder)

Group Type: OTHER

RisperiDONE 0.5 MG

Intervention Type: DRUG

To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.

Non responder

The 2 arms will be created according to the early response to risperidone (responder vs. non responder)

Group Type: OTHER

RisperiDONE 0.5 MG

Intervention Type: DRUG

To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.

Interventions

RisperiDONE 0.5 MG

To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marion Trousselard

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marion Trousselard

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bertrand Lahutte

Role: PRINCIPAL_INVESTIGATOR

HIA Begin Paris

Locations

Marion Trousselard

Brétigny-sur-Orge, Not in US/Canada, France

Countries

France

Other Identifiers

2016-000341-31

Identifier Type: -

Identifier Source: org_study_id