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

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

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.

Study Overview

• Status: Terminated
• Conditions: Anxiety State
• Intervention / Treatment: Drug: RisperiDONE 0.5 MG

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Not In US/Canada
    • Brétigny-sur-Orge, Not In US/Canada, France, 91223
      • Marion Trousselard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of anxiety	score in the Post-trauma CheckList 5	changes between baseline and day 1 and between baseline and week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	score in the Iowa Gambling Task	changes between baseline and day 1 and between baseline and week 12

Collaborators and Investigators

• Sponsor: Marion Trousselard
• Investigators: Principal Investigator: Bertrand Lahutte, HIA Begin Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: cognition; risperidone; anxiety; stress
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: 2016-000341-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No