Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
Primary Purpose
Anxiety State
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
RisperiDONE 0.5 MG
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety State focused on measuring risperidone, anxiety, cognition, stress
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
Sites / Locations
- Marion Trousselard
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Responder
Non responder
Arm Description
The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
Outcomes
Primary Outcome Measures
Anxiety
score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)
Secondary Outcome Measures
Type of anxiety
score in the Post-trauma CheckList 5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03227562
Brief Title
Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
Official Title
Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
not enough patient
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marion Trousselard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
Keywords
risperidone, anxiety, cognition, stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All subjects are under 0.5mg risperidone (one group). Accordin to their response to treatment (responder vs. non responder) the 2 experimental groups will be created.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Responder
Arm Type
Other
Arm Description
The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
Arm Title
Non responder
Arm Type
Other
Arm Description
The 2 arms will be created according to the early response to risperidone (responder vs. non responder)
Intervention Type
Drug
Intervention Name(s)
RisperiDONE 0.5 MG
Intervention Description
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
Primary Outcome Measure Information:
Title
Anxiety
Description
score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)
Time Frame
changes between baseline and day 1 and between baseline and week 12
Secondary Outcome Measure Information:
Title
Type of anxiety
Description
score in the Post-trauma CheckList 5
Time Frame
changes between baseline and day 1 and between baseline and week 12
Other Pre-specified Outcome Measures:
Title
Cognition
Description
score in the Iowa Gambling Task
Time Frame
changes between baseline and day 1 and between baseline and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Lahutte
Organizational Affiliation
HIA Begin Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marion Trousselard
City
Brétigny-sur-Orge
State/Province
Not In US/Canada
ZIP/Postal Code
91223
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
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