StrokePhase 4SELEISNCT02386475
Effect of Serotonin and Levodopa in Ischemic Stroke
A Phase 4 study testing citalopram and sinemet plus in people with Stroke, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- citalopram and sinemet plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to 31 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with a first stroke with NIHSS 5-20 points
- Patients without aphasia to avoid interference in the assessment of depression and cognitive impairment
- Patients with independent functional status prior to stroke (mRS <3)
- Patients without prior cognitive impairment or depressive syndrome assessed by medical history with the patient and family.
- The assigned treatment initiated within the first five days of stroke
Who cannot join
- • Patients with prior myocardial or cerebral hemorrhage
- Patients with TIA
- Patients with aphasia
- History of cognitive impairment or prior depressive syndrome
- Patients with no independent functional status mRS greater than or equal to 3
- Underlying disease hopefully less than one year of life.
- Patient pre-treatment with levodopa, an antidepressant or neuroleptic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction
Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.
Read the detailed description
Methods. Evaluate 240 consecutive patients with a first ischemic stroke with NIHSS 5-20 without aphasia and with a previous independent functional status (mRS <3). Patients will be randomized into four arms: 1) control group, 2) treatment with citalopram 20 mg / day, 3) group levodopa (sinemet plus)100 mg / day, 4) group levodopa (sinemet plus) 100 mg / day + citalopram 20 mg / day.
The treatment begins within the first 5 days of stroke and is maintained for 6 months. All patients will be treated according to current guidelines for secondary prevention. We will assess the following variables: demographic, vascular risk factors, etiologic subtypes according to TOAST criteria, neurologic deficit with the NIHSS scale, cognitive assessment with Minimental scale and functional status with scale modified Rankin at discharge, 3, 6 and 12 months, Symbol Digit Modalities Test (SDMT), GDS-15 Geriatric Depression Scale, Logical memory of WMS-IV . The cognitive assessment and motor functional status will be evaluated by a neuropsychologist and neurologist blinded to treatment assignment.
- Conditions
- Stroke
- Being tested
- placebo, citalopram, sinemet plus
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called control group
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
citalopramDrug
Also called citalopram group
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
sinemet plusDrug
Also called sinemet group
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. Receives: Other: placebo |
| citalopram 20 mg | Active comparator | In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. Receives: Drug: citalopram |
| sinemet plus 100 mg | Active comparator | In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. Receives: Drug: sinemet plus |
| Sinemet Plus + citalopram group | Active comparator | In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. Receives: Drug: citalopram; Drug: sinemet plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rankin Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dolores Cocho, Principal investigator, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386475
- Sponsor's protocol ID
- SELEIS
- Other IDs
- 2014-000846-32, 2014
- Acronym
- SELEIS
- Status last verified
- Aug 2017
- First submitted
- 6 Mar 2015
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Thrift AG, Dewey HM, Macdonell RA, McNeil JJ, Donnan GA. Stroke incidence on the east coast of Australia: the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2000 Sep;31(9):2087-92. doi: 10.1161/01.str.31.9.2087.
PubMed 10978034Bruel-Jungerman E, Rampon C, Laroche S. Adult hippocampal neurogenesis, synaptic plasticity and memory: facts and hypotheses. Rev Neurosci. 2007;18(2):93-114. doi: 10.1515/revneuro.2007.18.2.93.
PubMed 17593874Jin K, Minami M, Lan JQ, Mao XO, Batteur S, Simon RP, Greenberg DA. Neurogenesis in dentate subgranular zone and rostral subventricular zone after focal cerebral ischemia in the rat. Proc Natl Acad Sci U S A. 2001 Apr 10;98(8):4710-5. doi: 10.1073/pnas.081011098.
PubMed 11296300Arvidsson A, Collin T, Kirik D, Kokaia Z, Lindvall O. Neuronal replacement from endogenous precursors in the adult brain after stroke. Nat Med. 2002 Sep;8(9):963-70. doi: 10.1038/nm747. Epub 2002 Aug 5.
PubMed 12161747Yamashita T, Ninomiya M, Hernandez Acosta P, Garcia-Verdugo JM, Sunabori T, Sakaguchi M, Adachi K, Kojima T, Hirota Y, Kawase T, Araki N, Abe K, Okano H, Sawamoto K. Subventricular zone-derived neuroblasts migrate and differentiate into mature neurons in the post-stroke adult striatum. J Neurosci. 2006 Jun 14;26(24):6627-36. doi: 10.1523/JNEUROSCI.0149-06.2006.
PubMed 16775151Sun Y, Jin K, Xie L, Childs J, Mao XO, Logvinova A, Greenberg DA. VEGF-induced neuroprotection, neurogenesis, and angiogenesis after focal cerebral ischemia. J Clin Invest. 2003 Jun;111(12):1843-51. doi: 10.1172/JCI17977.
PubMed 12813020Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.
PubMed 11761469Lim CM, Kim SW, Park JY, Kim C, Yoon SH, Lee JK. Fluoxetine affords robust neuroprotection in the postischemic brain via its anti-inflammatory effect. J Neurosci Res. 2009 Mar;87(4):1037-45. doi: 10.1002/jnr.21899.
PubMed 18855941Ruscher K, Kuric E, Wieloch T. Levodopa treatment improves functional recovery after experimental stroke. Stroke. 2012 Feb;43(2):507-13. doi: 10.1161/STROKEAHA.111.638767. Epub 2011 Nov 17.
PubMed 22096034Gu Q. Neuromodulatory transmitter systems in the cortex and their role in cortical plasticity. Neuroscience. 2002;111(4):815-35. doi: 10.1016/s0306-4522(02)00026-x.
PubMed 12031406Costa RM. Plastic corticostriatal circuits for action learning: what's dopamine got to do with it? Ann N Y Acad Sci. 2007 May;1104:172-91. doi: 10.1196/annals.1390.015. Epub 2007 Apr 13.
PubMed 17435119Jacobs BL, Fornal CA. Serotonin and motor activity. Curr Opin Neurobiol. 1997 Dec;7(6):820-5. doi: 10.1016/s0959-4388(97)80141-9.
PubMed 9464975Martinsson L, Hardemark H, Eksborg S. Amphetamines for improving recovery after stroke. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD002090. doi: 10.1002/14651858.CD002090.pub2.
PubMed 17253474Treig T, Werner C, Sachse M, Hesse S. No benefit from D-amphetamine when added to physiotherapy after stroke: a randomized, placebo-controlled study. Clin Rehabil. 2003 Sep;17(6):590-9. doi: 10.1191/0269215503cr653oa.
PubMed 12971703Platz T, Kim IH, Engel U, Pinkowski C, Eickhof C, Kutzner M. Amphetamine fails to facilitate motor performance and to enhance motor recovery among stroke patients with mild arm paresis: interim analysis and termination of a double blind, randomised, placebo-controlled trial. Restor Neurol Neurosci. 2005;23(5-6):271-80.
PubMed 16477089
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction
- ClinicalTrials.gov ID
- NCT02386475
- Acronym / sponsor ID
- SELEIS / SELEIS
- Conditions
- Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Mar 2015 (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.
Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.
Detailed description
Methods. Evaluate 240 consecutive patients with a first ischemic stroke with NIHSS 5-20 without aphasia and with a previous independent functional status (mRS <3). Patients will be randomized into four arms: 1) control group, 2) treatment with citalopram 20 mg / day, 3) group levodopa (sinemet plus)100 mg / day, 4) group levodopa (sinemet plus) 100 mg / day + citalopram 20 mg / day.
The treatment begins within the first 5 days of stroke and is maintained for 6 months. All patients will be treated according to current guidelines for secondary prevention. We will assess the following variables: demographic, vascular risk factors, etiologic subtypes according to TOAST criteria, neurologic deficit with the NIHSS scale, cognitive assessment with Minimental scale and functional status with scale modified Rankin at discharge, 3, 6 and 12 months, Symbol Digit Modalities Test (SDMT), GDS-15 Geriatric Depression Scale, Logical memory of WMS-IV . The cognitive assessment and motor functional status will be evaluated by a neuropsychologist and neurologist blinded to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. |
| citalopram 20 mg | Active comparator | Drug: citalopramIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. |
| sinemet plus 100 mg | Active comparator | Drug: sinemet plusIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. |
| Sinemet Plus + citalopram group | Active comparator | Drug: citalopram, Drug: sinemet plusIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients with a first stroke with NIHSS 5-20 points
Key exclusion criteria (7 listed)
- • Patients with prior myocardial or cerebral hemorrhage
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 |
|---|---|---|
| placeboAlso: control groupIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. | Other | Placebo |
| citalopramAlso: citalopram groupIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. | Drug | Sinemet Plus + citalopram group, citalopram 20 mg |
| sinemet plusAlso: sinemet groupIn all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association. | Drug | Sinemet Plus + citalopram group, sinemet plus 100 mg |
Primary outcome
Rankin Scale
Time frame: 12 months
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 26 Nov 2019.
- Background: PubMed 10978034Thrift AG, Dewey HM, Macdonell RA, McNeil JJ, Donnan GA. Stroke incidence on the east coast of Australia: the North East Melbourne Stroke Incidence Study (NEMESIS). Stroke. 2000 Sep;31(9):2087-92. doi: 10.1161/01.str.31.9.2087.
- Background: PubMed 17593874Bruel-Jungerman E, Rampon C, Laroche S. Adult hippocampal neurogenesis, synaptic plasticity and memory: facts and hypotheses. Rev Neurosci. 2007;18(2):93-114. doi: 10.1515/revneuro.2007.18.2.93.
- Background: PubMed 11296300Jin K, Minami M, Lan JQ, Mao XO, Batteur S, Simon RP, Greenberg DA. Neurogenesis in dentate subgranular zone and rostral subventricular zone after focal cerebral ischemia in the rat. Proc Natl Acad Sci U S A. 2001 Apr 10;98(8):4710-5. doi: 10.1073/pnas.081011098.
- Background: PubMed 12161747Arvidsson A, Collin T, Kirik D, Kokaia Z, Lindvall O. Neuronal replacement from endogenous precursors in the adult brain after stroke. Nat Med. 2002 Sep;8(9):963-70. doi: 10.1038/nm747. Epub 2002 Aug 5.
- Background: PubMed 16775151Yamashita T, Ninomiya M, Hernandez Acosta P, Garcia-Verdugo JM, Sunabori T, Sakaguchi M, Adachi K, Kojima T, Hirota Y, Kawase T, Araki N, Abe K, Okano H, Sawamoto K. Subventricular zone-derived neuroblasts migrate and differentiate into mature neurons in the post-stroke adult striatum. J Neurosci. 2006 Jun 14;26(24):6627-36. doi: 10.1523/JNEUROSCI.0149-06.2006.
- Background: PubMed 12813020Sun Y, Jin K, Xie L, Childs J, Mao XO, Logvinova A, Greenberg DA. VEGF-induced neuroprotection, neurogenesis, and angiogenesis after focal cerebral ischemia. J Clin Invest. 2003 Jun;111(12):1843-51. doi: 10.1172/JCI17977.
- Background: PubMed 11761469Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol. 2001 Dec;50(6):718-29. doi: 10.1002/ana.1257.
- Background: PubMed 18855941Lim CM, Kim SW, Park JY, Kim C, Yoon SH, Lee JK. Fluoxetine affords robust neuroprotection in the postischemic brain via its anti-inflammatory effect. J Neurosci Res. 2009 Mar;87(4):1037-45. doi: 10.1002/jnr.21899.
- Background: PubMed 22096034Ruscher K, Kuric E, Wieloch T. Levodopa treatment improves functional recovery after experimental stroke. Stroke. 2012 Feb;43(2):507-13. doi: 10.1161/STROKEAHA.111.638767. Epub 2011 Nov 17.
- Background: PubMed 12031406Gu Q. Neuromodulatory transmitter systems in the cortex and their role in cortical plasticity. Neuroscience. 2002;111(4):815-35. doi: 10.1016/s0306-4522(02)00026-x.
- Background: PubMed 17435119Costa RM. Plastic corticostriatal circuits for action learning: what's dopamine got to do with it? Ann N Y Acad Sci. 2007 May;1104:172-91. doi: 10.1196/annals.1390.015. Epub 2007 Apr 13.
- Background: PubMed 9464975Jacobs BL, Fornal CA. Serotonin and motor activity. Curr Opin Neurobiol. 1997 Dec;7(6):820-5. doi: 10.1016/s0959-4388(97)80141-9.
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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.
Dolores Cocho principal investigator
Hospital de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing citalopram and sinemet plus in people with Stroke, run by Hospital de Granollers at 1 site in Spain.
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 7 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 26 Nov 2019. 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 Spain. 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?
Rankin Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386475, which also lists 26 linked publications.
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 26 Nov 2019.