Is Initial Response to Low Dose Risperidone Predictive fo... | NCT03227562

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

NCT03227562

Sponsor

Marion Trousselard

Status

Terminated

Last Update Posted

Aug 4, 2022Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Anxiety State

Interventions

RisperiDONE 0.5 MG

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough patient

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marion Trousselard, professor, Institut de Recherche Biomedicale des ArmeesSponsor-Investigator

Lead Sponsor

Marion TrousselardOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
RisperiDONE 0.5 MG	Drug	To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.	Non responder Responder

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bertrand Lahutte	HIA Begin Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marion Trousselard		Brétigny-sur-Orge	Not in US/Canada	91223	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

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.