Post-stroke DepressionPhase 2MRV-PSDNCT05932550
Safety of Maraviroc for Post-stroke Depression
A Phase 2 study testing Maraviroc 300 mg in people with Post-stroke Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 86 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Maraviroc 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Aug 2020to 4 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Maraviroc for Post-stroke Depression (Proof-of-concept)
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).
- Conditions
- Post-stroke Depression
- Being tested
- Maraviroc 300 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maraviroc 300 mgDrug
10 week treatment as add-on therapy to anti-depressants
| Study group | Role | What they receive |
|---|---|---|
| Maraviroc 300 mg/day | Experimental | Open-label study Receives: Drug: Maraviroc 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
depression score
Measured: 10 weeks
Secondary outcomes (3)
16-item quick inventory of depressive symptoms- self-report, QIDS-SR16
self-report depression score
Measured: 10 weeks
clinical global impression scale (CGI)
Clinician impression
Measured: 10 weeks
7-item patient-reported generalized anxiety disorder 7-item scale- GAD-7
Anxiety score
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start4 Aug 2020
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932550
- Sponsor's protocol ID
- 0056-20-TLV
- Acronym
- MRV-PSD
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data
Publications
Tene O, Molad J, Rotschild O, Alpernas A, Hawwari M, Seyman E, Giladi N, Hallevi H, Assayag EB. Blocking CCR5 activity by maraviroc augmentation in post-stroke depression: a proof-of-concept clinical trial. BMC Neurol. 2024 Jun 6;24(1):190. doi: 10.1186/s12883-024-03683-3.
PubMed 38844862
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Maraviroc for Post-stroke Depression (Proof-of-concept)
- ClinicalTrials.gov ID
- NCT05932550
- Acronym / sponsor ID
- MRV-PSD / 0056-20-TLV
- Conditions
- Post-stroke Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maraviroc 300 mg/day | Experimental | Drug: Maraviroc 300 mgOpen-label study |
Who may qualify
- Ages
- 50 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maraviroc 300 mg10 week treatment as add-on therapy to anti-depressants | Drug | Maraviroc 300 mg/day |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 10 weeks
depression score
3 secondary outcomes
16-item quick inventory of depressive symptoms- self-report, QIDS-SR16
Time frame: 10 weeks
clinical global impression scale (CGI)
Time frame: 10 weeks
7-item patient-reported generalized anxiety disorder 7-item scale- GAD-7
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 38844862Tene O, Molad J, Rotschild O, Alpernas A, Hawwari M, Seyman E, Giladi N, Hallevi H, Assayag EB. Blocking CCR5 activity by maraviroc augmentation in post-stroke depression: a proof-of-concept clinical trial. BMC Neurol. 2024 Jun 6;24(1):190. doi: 10.1186/s12883-024-03683-3.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maraviroc 300 mg in people with Post-stroke Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.