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

NCT03227562 | Terminated Phase 3

• 1 other identifier: 2016-000341-31
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State

Keywords

risperidone; anxiety; cognition; stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Type of anxiety

  changes between baseline and day 1 and between baseline and week 12

Other Outcomes (1)

• Cognition

  changes between baseline and day 1 and between baseline and week 12

Study Arms (2)

Responder

OTHER

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

Drug: RisperiDONE 0.5 MG

Non responder

OTHER

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

Drug: RisperiDONE 0.5 MG

Interventions

RisperiDONE 0.5 MG DRUG

To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.

Non responder; Responder

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marion Trousselard: lead

Study Sites (1)

Marion Trousselard

Brétigny-sur-Orge, Not in US/Canada, 91223, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bertrand Lahutte

  HIA Begin Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 24, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

FR (1)