search
Back to results

Safety of Maraviroc for Post-stroke Depression (MRV-PSD)

Primary Purpose

Post-stroke Depression

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Maraviroc 300 mg
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Depression

Eligibility Criteria

50 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Men and women aged 50 to 86 years; Able to fully comprehend and sign an informed consent form; Diagnosis of stroke/TIA prior to study entrance and evidence of ischemic infarct and/or lacunar infarcts on MRI (defined as sharply demarcated hypointense lesions <20mm on T1-weighted images with corresponding hypointense lesions with hyperintense rim on FLAIR) and/or deep Cerebral Microbleeds (CMB) (defined as round hypointense lesions on T2-weighted gradient echo-images with a diameter < 10 mm in neuroimaging. Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) diagnostic criteria for major depressive episode that developed up to 12 months after the documented stroke/TIA. Able to comply with scheduled visits, treatment plan, and other trial procedures; Treatment with other antidepressants is allowed but subjects will be asked not to change their regular treatment regime during the trial. Exclusion Criteria: Hemorrhages and cerebral edema (e.g., subarachnoid haemorrhage, intracerebral hemorrhage, subdural hematoma, epidural hematoma) Patients in a state of coma or with severe disturbance of consciousness, aphasia, agnosia, or deafness that subsequently affects expression and communication. Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes. Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia Patients diagnosed with dementia or major neurocognitive disorder as defined by DSM-5at screening, or other neurological conditions that might dominate the clinical picture (multiple sclerosis, Parkinson's disease, epilepsy, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, etc.) Subject has a history of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or elevated hepatic transaminases or bilirubin, or tests positive for HIV at Screening. History of renal insufficiency or serum creatinine over 1.6;; Subject has a current or past diagnosis of bipolar or related disorders, intellectual disability, cluster B personality disorder (e.g., borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder), psychotic disorder, schizophrenia, PTSD , and substance/alcohol use disorders other than nicotine in the past year (including barbiturates, methadone, opiates, cocaine, cannabinoids, and amphetamine/ methamphetamine). Subject has suicidal ideation with intent to act during the screening phase or on Day 1 per investigator's clinical judgment, or has a history of suicidal behavior within the past year; or subject has homicidal ideation/intent at Screening or on Day 1. Subject has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigatoris considered cured with minimal risk of recurrence). Subject has known allergies, hypersensitivity, intolerance, or contraindication to Maraviroc or its excipients. Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug or is currently enrolled in an investigational study. Subject is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Subject has had major surgery, (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Use of drugs with possible interactions with Maraviroc.

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maraviroc 300 mg/day

Arm Description

Open-label study

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
depression score

Secondary Outcome Measures

16-item quick inventory of depressive symptoms- self-report, QIDS-SR16
self-report depression score
clinical global impression scale (CGI)
Clinician impression
7-item patient-reported generalized anxiety disorder 7-item scale- GAD-7
Anxiety score

Full Information

First Posted
June 28, 2023
Last Updated
June 28, 2023
Sponsor
Tel-Aviv Sourasky Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05932550
Brief Title
Safety of Maraviroc for Post-stroke Depression
Acronym
MRV-PSD
Official Title
Safety of Maraviroc for Post-stroke Depression (Proof-of-concept)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Post-stroke depression (PSD) is a barrier to effective rehabilitation and recovery after stroke. Current treatment options are limited and there is an unmet need for specific and effective therapeutic options. Objective: To examine the safety and efficacy of Maraviroc, a CCR5 antagonist, as a possible add-on treatment option for PSD, in an open-labeled proof-of-concept clinical trial. Design, Setting, and Participants: A 10-week trial of daily oral 300 mg Maraviroc in ten patients with subcortical stroke suffering from PSD. Follow-up: eight weeks after completing treatment. Main Outcome Measure: A change in the Montgomery-Asberg Depression Rating Scale (MADRS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maraviroc 300 mg/day
Arm Type
Experimental
Arm Description
Open-label study
Intervention Type
Drug
Intervention Name(s)
Maraviroc 300 mg
Intervention Description
10 week treatment as add-on therapy to anti-depressants
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
depression score
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
16-item quick inventory of depressive symptoms- self-report, QIDS-SR16
Description
self-report depression score
Time Frame
10 weeks
Title
clinical global impression scale (CGI)
Description
Clinician impression
Time Frame
10 weeks
Title
7-item patient-reported generalized anxiety disorder 7-item scale- GAD-7
Description
Anxiety score
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged 50 to 86 years; Able to fully comprehend and sign an informed consent form; Diagnosis of stroke/TIA prior to study entrance and evidence of ischemic infarct and/or lacunar infarcts on MRI (defined as sharply demarcated hypointense lesions <20mm on T1-weighted images with corresponding hypointense lesions with hyperintense rim on FLAIR) and/or deep Cerebral Microbleeds (CMB) (defined as round hypointense lesions on T2-weighted gradient echo-images with a diameter < 10 mm in neuroimaging. Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) diagnostic criteria for major depressive episode that developed up to 12 months after the documented stroke/TIA. Able to comply with scheduled visits, treatment plan, and other trial procedures; Treatment with other antidepressants is allowed but subjects will be asked not to change their regular treatment regime during the trial. Exclusion Criteria: Hemorrhages and cerebral edema (e.g., subarachnoid haemorrhage, intracerebral hemorrhage, subdural hematoma, epidural hematoma) Patients in a state of coma or with severe disturbance of consciousness, aphasia, agnosia, or deafness that subsequently affects expression and communication. Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes. Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia Patients diagnosed with dementia or major neurocognitive disorder as defined by DSM-5at screening, or other neurological conditions that might dominate the clinical picture (multiple sclerosis, Parkinson's disease, epilepsy, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, etc.) Subject has a history of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or elevated hepatic transaminases or bilirubin, or tests positive for HIV at Screening. History of renal insufficiency or serum creatinine over 1.6;; Subject has a current or past diagnosis of bipolar or related disorders, intellectual disability, cluster B personality disorder (e.g., borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder), psychotic disorder, schizophrenia, PTSD , and substance/alcohol use disorders other than nicotine in the past year (including barbiturates, methadone, opiates, cocaine, cannabinoids, and amphetamine/ methamphetamine). Subject has suicidal ideation with intent to act during the screening phase or on Day 1 per investigator's clinical judgment, or has a history of suicidal behavior within the past year; or subject has homicidal ideation/intent at Screening or on Day 1. Subject has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigatoris considered cured with minimal risk of recurrence). Subject has known allergies, hypersensitivity, intolerance, or contraindication to Maraviroc or its excipients. Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug or is currently enrolled in an investigational study. Subject is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Subject has had major surgery, (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Use of drugs with possible interactions with Maraviroc.
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data

Learn more about this trial

Safety of Maraviroc for Post-stroke Depression

We'll reach out to this number within 24 hrs