Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity

• Status: Withdrawn
• Trial end date: 2021-02-09
• Target enrollment: 0
• Participant gender: All

Summary

The brain is able to change throughout life in response to learning, or injury, or to adapt to changes in the environment, which is known as neuroplasticity. Stroke survivors suffer disabling chronic motor impairments that have proven challenging to improve. Increasing neuroplasticity using selective serotonin reuptake inhibitors (SSRIs) is a promising approach to promote motor recovery in patients with stroke.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Burke Medical Research Institute
• Treatments: Citalopram; Dexetimide; Serotonin; Serotonin Uptake Inhibitors

Criteria

Neurological Healthy Participants Inclusion criteria

1. Men and women aged 18 years and older.

2. Ability to give informed consent.

Exclusion criteria

1. Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker

2. Current or history of neurological disorders or brain lesions such as stroke, multiple sclerosis, tumor, traumatic brain injury, spinal cord injury

3. Diagnosis of major depressive disorder or other psychiatric disorder

4. Currently taking escitalopram or another selective serotonin reuptake inhibitor

5. Currently taking or have taken in the past month other medications or supplements that have known interactions with escitalopram or can precipitate serotonin syndrome when taken in combination with escitalopram: monoamine oxidase inhibitors, methylene blue, linezolid, serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort

6. Known hypersensitivity to escitalopram or any of its inactive ingredients.

7. History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.

8. History of prolonged QTc

9. Pregnant or breastfeeding

10. Social and/or personal circumstances that interfere with the ability to return for all study visits.

Stroke Patients Inclusion criteria

1. Men and women aged 18 years and older.

2. Ability to give informed consent.

3. History of ischemic stroke

Exclusion criteria

1. Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker

2. Current or history of neurological disorders or brain lesions such as multiple sclerosis, tumor, traumatic brain injury, spinal cord injury

3. Diagnosis of major depressive disorder or other psychiatric disorder

4. Currently taking escitalopram or another selective serotonin reuptake inhibitor

5. Currently taking or have taken in the past month other medications or supplements that have known interactions with escitalopram or can precipitate serotonin syndrome when taken in combination with escitalopram: monoamine oxidase inhibitors, methylene blue, linezolid, serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants (TCAs), fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort

6. Known hypersensitivity to escitalopram or any of its inactive ingredients.

7. History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.

8. History of prolonged QTc

9. Pregnant or breastfeeding

10. Social and/or personal circumstances that interfere with the ability to return for all study visits.