Cortical Ischemic Stroke and Serotonin "CISS"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- First-ever stroke
- Clinically significant contralesional hand plegia or paresis as a main symptom
- Involvement of the pre-and/or postcentral gyri confirmed on diffusion-weighted (DWI) and fluid attenuated inversion recovery (FLAIR) scans.
- Written informed consent

Exclusion Criteria

- Aphasia or cognitive deficits severe enough to preclude understanding of study purposes
- Prior cerebrovascular events
- Significant stenosis (70-99% according to NASCET) or occlusion of the carotid and intracranial arteries on MR-angiography
- Purely subcortical stroke
- Known brain lesion (tumour, old cerebral haemorrhage)
- Other medical conditions interfering with task performance or SSRI-treatment, specifically: prolonged corrected QT interval (QTc) on electrocardiogram, ongoing drug / alcohol abuse
- Simultaneous intake of medications which can lead to prolonged QTc syndrome known or or suspected hypersensitivity (allergic) to one of the ingredients of Cipralex® or Placebo
- Simultaneous administration of: antidepressants, irreversible non- selective Monoamine Oxidase (MAO) inhibitors, reversible selective MAO inhibitors, reversible non-selective MAO inhibitors, irreversible selective MAO inhibitors, N-methyl-D-aspartate(NMDA)-receptor antagonists/-agonists, dopamine antagonists/-agonists, levodopa, benzodiazepines, amphetamines, methylphenidate, foscarnet, ganciclovir, ritonavir, mianserin, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, anticholinergics,systemic antihistamines, systemic sympathomimetics
- Conditions interfering with MRI such as patients with magnetic (metallic) particles in the scull or brain, patients with a cardiac pacemaker, deep brain stimulators or cochlear implant.
- Women who are pregnant or breastfeeding
- Women in childbearing age without sufficient birth control (at least 2 contraceptive methods)
Eligibility Criteria for healthy volunteers:
- Normal test-scores at the baseline visit (see section 5.2.2)
- Normal neurological status
- No known brain lesion
- No pregnancy
- Written informed consent