NCT02386475

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4 stroke

Timeline
Completed

Started Jan 2015

Typical duration for phase_4 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 26, 2019

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

March 6, 2015

Last Update Submit

November 25, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Rankin Scale

    12 months

Study Arms (4)

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.

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.

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.

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.

Drug: citalopramDrug: sinemet plus

Interventions

placeboOTHER

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.

Also known as: control group
Placebo
citalopramDRUG

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.

Also known as: citalopram group
Sinemet Plus + citalopram groupcitalopram 20 mg
sinemet plusDRUG

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.

Also known as: sinemet group
Sinemet Plus + citalopram groupsinemet plus 100 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Granollers General Hospital

Granollers, Barcelnoa, 08402, Spain

Location

Related Publications (26)

  • 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.

    PMID: 10978034BACKGROUND

  • Bruel-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.

    PMID: 17593874BACKGROUND

  • Jin 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.

    PMID: 11296300BACKGROUND

  • Arvidsson 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.

    PMID: 12161747BACKGROUND

  • Yamashita 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.

    PMID: 16775151BACKGROUND

  • Sun 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.

    PMID: 12813020BACKGROUND

  • Pariente 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.

    PMID: 11761469BACKGROUND

  • Lim 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.

    PMID: 18855941BACKGROUND

  • Ruscher 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.

    PMID: 22096034BACKGROUND

  • Gu 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.

    PMID: 12031406BACKGROUND

  • Costa 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.

    PMID: 17435119BACKGROUND

  • Jacobs BL, Fornal CA. Serotonin and motor activity. Curr Opin Neurobiol. 1997 Dec;7(6):820-5. doi: 10.1016/s0959-4388(97)80141-9.

    PMID: 9464975BACKGROUND

  • Martinsson 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.

    PMID: 17253474BACKGROUND

  • Treig 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.

    PMID: 12971703BACKGROUND

  • Platz 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.

    PMID: 16477089BACKGROUND

  • Gladstone DJ, Danells CJ, Armesto A, McIlroy WE, Staines WR, Graham SJ, Herrmann N, Szalai JP, Black SE; Subacute Therapy with Amphetamine and Rehabilitation for Stroke Study Investigators. Physiotherapy coupled with dextroamphetamine for rehabilitation after hemiparetic stroke: a randomized, double-blind, placebo-controlled trial. Stroke. 2006 Jan;37(1):179-85. doi: 10.1161/01.STR.0000195169.42447.78. Epub 2005 Dec 1.

    PMID: 16322487BACKGROUND

  • Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.

    PMID: 21216670BACKGROUND

  • Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Ischemic stroke subtypes : a population-based study of functional outcome, survival, and recurrence. Stroke. 2000 May;31(5):1062-8. doi: 10.1161/01.str.31.5.1062.

    PMID: 10797166BACKGROUND

  • Grade C, Redford B, Chrostowski J, Toussaint L, Blackwell B. Methylphenidate in early poststroke recovery: a double-blind, placebo-controlled study. Arch Phys Med Rehabil. 1998 Sep;79(9):1047-50. doi: 10.1016/s0003-9993(98)90169-1.

    PMID: 9749682BACKGROUND

  • Robinson RG, Schultz SK, Castillo C, Kopel T, Kosier JT, Newman RM, Curdue K, Petracca G, Starkstein SE. Nortriptyline versus fluoxetine in the treatment of depression and in short-term recovery after stroke: a placebo-controlled, double-blind study. Am J Psychiatry. 2000 Mar;157(3):351-9. doi: 10.1176/appi.ajp.157.3.351.

    PMID: 10698809BACKGROUND

  • Bilge C, Kocer E, Kocer A, Turk Boru U. Depression and functional outcome after stroke: the effect of antidepressant therapy on functional recovery. Eur J Phys Rehabil Med. 2008 Mar;44(1):13-8.

    PMID: 18385623BACKGROUND

  • Saxena SK, Ng TP, Koh G, Yong D, Fong NP. Is improvement in impaired cognition and depressive symptoms in post-stroke patients associated with recovery in activities of daily living? Acta Neurol Scand. 2007 May;115(5):339-46. doi: 10.1111/j.1600-0404.2006.00751.x.

    PMID: 17489945BACKGROUND

  • Sonde L, Lokk J. Effects of amphetamine and/or L-dopa and physiotherapy after stroke - a blinded randomized study. Acta Neurol Scand. 2007 Jan;115(1):55-9. doi: 10.1111/j.1600-0404.2006.00728.x.

    PMID: 17156266BACKGROUND

  • Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke. 1996 Jul;27(7):1211-4. doi: 10.1161/01.str.27.7.1211.

    PMID: 8685930BACKGROUND

  • Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial. Stroke. 2005 Jan;36(1):80-5. doi: 10.1161/01.STR.0000149623.24906.63. Epub 2004 Nov 29.

    PMID: 15569875BACKGROUND

  • Cooke EV, Mares K, Clark A, Tallis RC, Pomeroy VM. The effects of increased dose of exercise-based therapies to enhance motor recovery after stroke: a systematic review and meta-analysis. BMC Med. 2010 Oct 13;8:60. doi: 10.1186/1741-7015-8-60.

    PMID: 20942915BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Control GroupsCitalopramcarbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dolores Cocho

    Hospital de Granollers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 12, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2017

Study Completion

October 31, 2019

Last Updated

November 26, 2019

Record last verified: 2017-08

Locations

ES(1)