Effect of Serotonin and Levodopa in Ischemic Stroke

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: citalopram; Other: placebo; Drug: sinemet plus

• Registration Number: NCT02386475
• Lead Sponsor: Hospital de Granollers

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.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Primary Completion: 2017-03
• Status Verified: 2017-08
• Study Completion: 2019-10-31
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinemet Plus + citalopram group	sinemet plus	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.
citalopram 20 mg	citalopram	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.
Placebo	placebo	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 plus 100 mg	sinemet plus	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 Plus + citalopram group	citalopram	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.

Primary Outcome Measures

Name	Time	Method
Rankin Scale	12 months

Trial Locations

Locations (1)

Granollers General Hospital; 🇪🇸 Granollers, Barcelnoa, Spain