Anxiety StatePhase 3NCT03227562
Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
A Phase 3 study testing RisperiDONE 0.5 MG in people with Anxiety State, run by Marion Trousselard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anxiety State
- What is being tested?
- RisperiDONE 0.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 1 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Anxiety State
- Being tested
- RisperiDONE 0.5 MG
- Keywords
- risperidone, anxiety, cognition, stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperiDONE 0.5 MGDrug
To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Responder | Other | The 2 arms will be created according to the early response to risperidone (responder vs. non responder) Receives: 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) Receives: Drug: RisperiDONE 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
score in Anxiety scale in the Hospital Anxiety Depression Scale (HADs)
Measured: changes between baseline and day 1 and between baseline and week 12
Secondary outcomes (1)
Type of anxiety
score in the Post-trauma CheckList 5
Measured: changes between baseline and day 1 and between baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Why it stopped: not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marion Trousselard
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Marion Trousselard, Institut de Recherche Biomedicale des Armees
- Investigators
- Bertrand Lahutte, Principal investigator, HIA Begin Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227562
- Sponsor's protocol ID
- 2016-000341-31
- Other IDs
- 2016
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects
- ClinicalTrials.gov ID
- NCT03227562
- Acronym / sponsor ID
- 2016-000341-31
- Conditions
- Anxiety State
- Keywords
- risperidone, anxiety, cognition, stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patient
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marion TrousselardOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Responder | Other | Drug: RisperiDONE 0.5 MGThe 2 arms will be created according to the early response to risperidone (responder vs. non responder) |
| Non responder | Other | Drug: RisperiDONE 0.5 MGThe 2 arms will be created according to the early response to risperidone (responder vs. non responder) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Psychiatric antecedents
- any treatment for mental disease (antidepressant, anxiolytics, etc.)
- Ongoing neurological pathologies
- Scheduled surgery
- addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperiDONE 0.5 MGTo be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled. | Drug | Non responder, Responder |
Primary outcome
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)
1 secondary outcome
Type of anxiety
Time frame: changes between baseline and day 1 and between baseline and week 12
Results and safety
The study was stopped early (reason given: not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Lahutte principal investigator
HIA Begin Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RisperiDONE 0.5 MG in people with Anxiety State, run by Marion Trousselard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: changes between baseline and day 1 and between baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.