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

NCT04221256 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HMRL-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic

Keywords

Selective Serotonin Reuptake Inhibitor; Neuroplasticity; Paired Associative Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in motor evoked potential amplitude

  Assessment of corticospinal excitability

  Baseline, Up to 30 minutes Post PAS

Study Arms (2)

Administration of SSRI

EXPERIMENTAL

Participants will be administered either 5, 10 or 20mg of SSRI escitalopram prior to paired associative stimulation.

Drug: Administration of SSRI escitalopram; Behavioral: Paired Associative stimulation

Administration of Placebo

PLACEBO COMPARATOR

Participants will be administered a placebo prior to paired associative stimulation

Behavioral: Paired Associative stimulation; Drug: Administration of Placebo

Interventions

Administration of SSRI escitalopram DRUG

Participants will be administered 5, 10 or 20mg of SRRI escitalopram prior to paired associative stimulation

Administration of SSRI

Paired Associative stimulation BEHAVIORAL

Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.

Administration of Placebo; Administration of SSRI

Administration of Placebo DRUG

Participants will be administered a placebo prior to paired associative stimulation

Administration of Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 years and older.
• Ability to give informed consent.

You may not qualify if:

• Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
• Current or history of neurological disorders or brain lesions such as stroke, multiple sclerosis, tumor, traumatic brain injury, spinal cord injury
• Diagnosis of major depressive disorder or other psychiatric disorder
• Currently taking escitalopram or another selective serotonin reuptake inhibitor
• 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
• Known hypersensitivity to escitalopram or any of its inactive ingredients.
• History of cerebral hemorrhage, gastrointestinal bleeding, or genitourinary bleeding.
• History of prolonged QTc
• Pregnant or breastfeeding
• Social and/or personal circumstances that interfere with the ability to return for all study visits.
• Men and women aged 18 years and older.
• Ability to give informed consent.
• History of ischemic stroke
• Contraindications to TMS: epilepsy or other seizure history, ferromagnetic metallic implants in the head, or pacemaker
• Current or history of neurological disorders or brain lesions such as multiple sclerosis, tumor, traumatic brain injury, spinal cord injury

Sponsors & Collaborators

• Burke Medical Research Institute: lead

Study Sites (1)

Burke Neurological Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tomoko Kitago, MD

  Winifred Masterson Burke Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lab Director Human Motor Recovery Laboratory Assistant Professor

Model Details: We propose a double-blinded, placebo-controlled crossover study to test a range of doses of escitalopram and a placebo control in enhancing PAS-induced plasticity in healthy individuals without neurological disease and patients with chronic stroke.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: March 11, 2020
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)