NCT02063425

Brief Summary

The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke. In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

January 6, 2014

Last Update Submit

October 18, 2017

Conditions

Cerebral Infarction

Keywords

Motor recoveryFluoxetineTranscranial magnetic stimulationstroke

Outcome Measures

Primary Outcomes (1)

  • Slope of the curve of recruitment of the PEMs

    Significant difference, between the treated group and the group control, of the slope of the curve of recruitment of the PEMs between the beginning (D0) and the end of the treatment (processing) (M3).

    M3

Secondary Outcomes (4)

  • Slope of recruitment of the PEMs

    D0, M3, M6

  • Slope of recruitment of the PEMs

    D0, M3, M6

  • Index finger force control in paretic hand under time-course of treatment of Fluoxetine

    D0, M3, M6

  • in index finger force control in non-paretic hand under time-course of treatment of Fluoxetine

    D0, M3, M6

Study Arms (2)

Fluoxetine

ACTIVE COMPARATOR
Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR
Drug: Placebo of fluoxetine

Interventions

FluoxetineDRUG

1 pill of 20mg / day, during 3 months

Also known as: Patients receiving fluoxetine
Fluoxetine
Placebo of fluoxetineDRUG

1 pill of 20mg/day, during 3 months

Also known as: Patients receiving placebo
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man and women, aged from 18 to 80 years.
  • Social security affiliation
  • Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand \< or = 10)
  • Informed consent

You may not qualify if:

  • Score NIHSS \> 20
  • Depression (criteria DSM5-R) with MADRS score \> 19
  • History of recurrent bipolar or depressive disorders.
  • History of behavior or suicidal idea
  • Family history of extension of the interval QT or congenital long interval QT
  • History of clinical stroke
  • Aphasia preventing correct evaluation of motor and depression scales.
  • Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
  • Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill)
  • Severe swallowing disorders preventing oral administration of the treatment
  • Planned carotid surgery
  • Pregnant or breast-feeding woman
  • Hepatic failure (TGO and TGP \>2N); severe renal failure (creatinine \>180micromol/l)
  • Concomitant severe disease not allowing follow-up.
  • Participation to another therapeutic study.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, 75674, France

Location

MeSH Terms

Conditions

Cerebral InfarctionStroke

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Jean-Claude BARON, MD

    Centre Hospitalier Sainte-Anne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

FR(1)