Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Responder The 2 arms will be created according to the early response to risperidone (responder vs. non responder) |
Drug: RisperiDONE 0.5 MG
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
|
| Other: Non responder The 2 arms will be created according to the early response to risperidone (responder vs. non responder) |
Drug: RisperiDONE 0.5 MG
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
|
Outcome Measures
Primary Outcome Measures
- 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
- Type of anxiety [changes between baseline and day 1 and between baseline and week 12]
score in the Post-trauma CheckList 5
Other Outcome Measures
- Cognition [changes between baseline and day 1 and between baseline and week 12]
score in the Iowa Gambling Task
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Marion Trousselard | Brétigny-sur-Orge | Not In US/Canada | France | 91223 |
Sponsors and Collaborators
- Marion Trousselard
Investigators
- Principal Investigator: Bertrand Lahutte, HIA Begin Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-000341-31