StrokePhase 4RECONISENCT02767999
Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
A Phase 4 study testing Fluoxetine and fMRI in people with Stroke, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Fluoxetine and fMRI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Feb 2017to 31 Jan 2022
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever ischemic stroke
- Cortical or subcortical stroke
- National Institute of Health Stroke Scale NIHSS>12 or motor NIHSS>6 at inclusion
- MRI-proved ischemic stroke
Who cannot join
- pregnant or breast-feeding women
- alcoholism
- ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption < 1 month
- allergic reaction after SSRI administration
- MRI contraindication
- NIHSS>22
- Severe aphasia
- Coma
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
Read the detailed description
In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.
- Conditions
- Stroke
- Being tested
- Fluoxetine, Placebo, fMRI
- Keywords
- Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
20 mg of fluoxetine capsule per day from D0 to D90
PlaceboDrug
cellulose placebo per day from D0 to D90
fMRIRadiation
functional resting state MRI
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI Receives: Drug: Fluoxetine; Radiation: fMRI |
| Placebo | Placebo comparator | The other group will take a cellulose placebo per day from D0 to D90 and have fMRI Receives: Drug: Placebo; Radiation: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracerebral connectivity in the motor network between fluoxetine and placebo group.
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.
Measured: 90 days
Secondary outcomes (2)
Intracerebral connectivity in the motor network between good responders patients
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in fluoxetine and placebo good responders patients, defined by :
- 8 points gain on the National Institute of Health Stroke Scale (NIHSS), assessed between D0 and D30 and between D0 and D90
- or 2 points gain on the modified Rankin score (mRS) assessed between D0 and D30 and between D0 and D90.
Measured: 90 days
Intracerebral connectivity in the motor network between non-responders patients
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start27 Feb 2017
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CHOLLET, MD PhD, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767999
- Sponsor's protocol ID
- RC31/14/7388
- Acronym
- RECONISE
- Status last verified
- Aug 2023
- First submitted
- 6 May 2016
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02767999
- Acronym / sponsor ID
- RECONISE / RC31/14/7388
- Conditions
- Stroke
- Keywords
- Acute ischemic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
Detailed description
In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: Fluoxetine, Radiation: fMRIOne group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI |
| Placebo | Placebo comparator | Drug: Placebo, Radiation: fMRIThe other group will take a cellulose placebo per day from D0 to D90 and have fMRI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-ever ischemic stroke
- Cortical or subcortical stroke
- National Institute of Health Stroke Scale NIHSS>12 or motor NIHSS>6 at inclusion
- MRI-proved ischemic stroke
Key exclusion criteria (8 listed)
- pregnant or breast-feeding women
- alcoholism
- ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption < 1 month
- allergic reaction after SSRI administration
- MRI contraindication
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 |
|---|---|---|
| Fluoxetine20 mg of fluoxetine capsule per day from D0 to D90 | Drug | Fluoxetine |
| Placebocellulose placebo per day from D0 to D90 | Drug | Placebo |
| fMRIfunctional resting state MRI | Radiation | Fluoxetine, Placebo |
Primary outcome
Intracerebral connectivity in the motor network between fluoxetine and placebo group.
Time frame: 90 days
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.
2 secondary outcomes
Intracerebral connectivity in the motor network between good responders patients
Time frame: 90 days
Intracerebral connectivity in the motor network between non-responders patients
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
François CHOLLET, MD PhD study director
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine and fMRI in people with Stroke, run by University Hospital, Toulouse at 2 sites 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 4 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: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intracerebral connectivity in the motor network between fluoxetine and placebo group. (time frame: 90 days). 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 28 Aug 2023.