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

Marion Trousselard

Status and phase: Terminated; Phase 3

Conditions: Anxiety State

Treatments: Drug: RisperiDONE 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03227562

2016-000341-31

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Responder

Other group

Description:

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

Treatment:

Drug: RisperiDONE 0.5 MG

Non responder

Other group

Description:

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

Treatment:

Drug: RisperiDONE 0.5 MG