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

Anxiety State Clinical Trial

Official title:

Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03227562
• Other study ID #: 2016-000341-31
• Status: Terminated
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

Intervention

Drug:
• RisperiDONE 0.5 MG
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.

Locations

Country	Name	City	State
France	Marion Trousselard	Brétigny-sur-Orge	Not In US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Marion Trousselard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition	score in the Iowa Gambling Task	changes between baseline and day 1 and between baseline and week 12
Primary	Anxiety	score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)	changes between baseline and day 1 and between baseline and week 12
Secondary	Type of anxiety	score in the Post-trauma CheckList 5	changes between baseline and day 1 and between baseline and week 12