Evidence map›Paper›PMID 38844862›Full record

Trial reportBMC neurology2024

Blocking CCR5 activity by maraviroc augmentation in post-stroke depression: a proof-of-concept clinical trial.

Oren Tene, Jeremy Molad, Ofer Rotschild, Aviva Alpernas, Muhamad Hawwari, Estelle Seyman, Nir Giladi, Hen Hallevi, Einor Ben Assayag

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05932550 (Safety of Maraviroc for Post-stroke Depression), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05932550 phase2completednot on this map

Safety of Maraviroc for Post-stroke Depression (Proof-of-concept)

TypeinterventionalSponsorTel-Aviv Sourasky Medical CenterRan2020 to 2022Enrolled10ConditionsPost-stroke DepressionArmsMaraviroc 300 mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Oren TeneDepartment of Psychiatry, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Jeremy MoladDepartment of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel.
Ofer RotschildDepartment of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel.
Aviva AlpernasDepartment of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel.
Muhamad HawwariDepartment of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel.
Estelle SeymanDepartment of Neurology-Stroke, Rambam Medical Center, Haifa, Israel.
Nir GiladiBrain Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Hen Hallevi *Department of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel.
Einor Ben Assayag *Department of Neurology, Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel. einorba@tlvmc.gov.il.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPost-stroke depression (PSD) is a significant impediment to successful rehabilitation and recovery after a stroke. Current therapeutic options are limited, leaving an unmet demand for specific and effective therapeutic options. Our objective was to investigate the safety of Maraviroc, a CCR5 antagonist, as a possible mechanism-based add-on therapeutic option for PSD in an open-label proof-of-concept clinical trial.

methodsWe conducted a 10-week clinical trial in which ten patients with subcortical and cortical stroke, suffering from PSD. were administered a daily oral dose of 300 mg Maraviroc. Participants were then monitored for an additional eight weeks. The primary outcome measure was serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation. The secondary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS).

resultsMaraviroc was well tolerated, with no reports of serious adverse events or discontinuations due to intolerance. The MADRS scores substantially reduced from baseline to week 10 (mean change: -16.4 ± 9.3; p < 0.001). By the conclusion of the treatment phase, a favorable response was observed in five patients, with four achieving remission. The time to response was relatively short, approximately three weeks. After the cessation of treatment, MADRS scores increased at week 18 by 6.1 ± 9.6 points (p = 0.014).

conclusionsOur proof-of-concept study suggests that a daily dosage of 300 mg of Maraviroc may represent a well-tolerated and potentially effective pharmacological approach to treating PSD. Further comprehensive placebo-controlled studies are needed to assess the impact of Maraviroc augmentation on PSD.

trial registrationClinicalTrials.gov Identifier: NCT05932550, Retrospectively registered: 28/06/2023.

Indexed as

CCR5 Receptor AntagonistsMaravirocProof of Concept StudyStrokeAdultAgedDepressionFemaleHumansMaleMiddle AgedReceptors, CCR5Treatment OutcomeTriazolesCCR5 protein, humanCCR5 Receptor AntagonistsMaravirocReceptors, CCR5TriazolesCCR5 antagonistClinical trialDrug repurposingMaravirocPost-stroke depression (PSD)

Identifiers

PMID38844862
PMCPMC11155100

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.