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

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ClinicalTrials.gov Identifier: NCT03227562
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marion Trousselard, Institut de Recherche Biomedicale des Armees

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
Anxiety State Drug: RisperiDONE 0.5 MG 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 1, 2017
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Risperidone

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Anxiety [ Time Frame: 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 :
  1. Type of anxiety [ Time Frame: changes between baseline and day 1 and between baseline and week 12 ]
    score in the Post-trauma CheckList 5


Other Outcome Measures:
  1. Cognition [ Time Frame: changes between baseline and day 1 and between baseline and week 12 ]
    score in the Iowa Gambling Task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227562


Contacts
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Contact: Bertrand Lahutte, MD (33)143985440 bertrand.lahutte@intradef.gouv.fr
Contact: Frederic Canini, MD PhD (33)178651257 frederic.canini@intradef.gouv.fr

Locations
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France
Marion Trousselard Recruiting
Brétigny-sur-Orge, Not In US/Canada, France, 91223
Contact: marion trousselard    0603771727    marion.trousselard@gmail.com   
Sponsors and Collaborators
Marion Trousselard
Investigators
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Principal Investigator: Bertrand Lahutte HIA Begin Paris

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Responsible Party: Marion Trousselard, professor, Institut de Recherche Biomedicale des Armees
ClinicalTrials.gov Identifier: NCT03227562    
Other Study ID Numbers: 2016-000341-31
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marion Trousselard, Institut de Recherche Biomedicale des Armees:
risperidone
anxiety
cognition
stress
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents