Evidence map›Paper›PMID 39650201›Full record

ArticleThe South African journal of psychiatry : SAJP : the journal of the Society of Psychiatrists of South Africa2024

Safety and effectiveness of methylphenidate ER multi-unit pellet system in ADHD patients: An open label study.

Renata Schoeman, Evelyn Y Lai, Anne-Marie Nel, Mashra Gani, Muhammed A Fulat, Akbar A Mahomed

Abstract read
In one paragraph

Article in The South African journal of psychiatry : SAJP : the journal of the Society of Psychiatrists of South Africa, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

6 authors.

Renata SchoemanStellenbosch Business School, Stellenbosch University, Stellenbosch, South Africa.ORCID https://orcid.org/0000-0003-1563-7517
Evelyn Y LaiDepartment of Medical Affairs, Mylan (Pty) Ltd, Johannesburg, South Africa.ORCID https://orcid.org/0000-0001-9445-828X
Anne-Marie NelRobert Broom Medical Centre, Krugersdorp, South Africa.ORCID https://orcid.org/0000-0001-5929-4603
Mashra GaniSmartmed CTC, Port Elizabeth, South Africa.ORCID https://orcid.org/0009-0005-7401-4901
Muhammed A FulatClinical Trial Systems, Pretoria, South Africa.ORCID https://orcid.org/0000-0002-6401-5813
Akbar A MahomedZinakekele Medical Centre, Mpumalanga, South Africa.ORCID https://orcid.org/0000-0003-0479-6205

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Attention deficit hyperactive disorder (ADHD) is a neurodevelopmental disorder occurring in children and adults. Pharmacotherapy remains the cornerstone of ADHD treatment. Stimulants such as methylphenidate are effective and have been one of the best studied and most frequently used treatment for ADHD. However, different delivery mechanisms and devices may potentially impact patient experience and real-life outcomes. Aim: This study evaluated the effectiveness of Multiple-Unit Pellet System Delivered Extended-Release Methylphenidate (Contramyl XR) on symptom control and reported outcomes in ADHD patients, in a real-world setting. Setting: A phase IV, open label, flexible dose, prospective, observational study conducted at six sites covering five provinces of South Africa. Methods: About 119 participants with ADHD (both newly diagnosed [treatment-naïve] and methylphenidate-treated [switch-over] patients) were enrolled and initiated either on Contramyl XR or switched over from methylphenidate to Contramyl XR. Primary efficacy was assessed by Weiss Functional Impairment Rating Scale (WFIRS) over 12 weeks. Results: In all, 117 participants completed the study (treatment-naïve patients: 46% [ Conclusion: Contramyl XR was found to be clinically effective either as de novo or as switch therapy. It was well tolerated, and all patients chose to continue with the treatment option. Contribution: Despite distinct and different delivery mechanism of Contramyl XR, this study provides evidence for using it as an alternate treatment option versus reference methylphenidate, in both treatment-naïve and switch-over ADHD patients. Study participants willingness to continue Contramyl XR therapy post study, further strengthens the confidence on the effectiveness of Contramyl XR in managing ADHD patients.

Indexed as

attention deficit hyperactive disorderContramyl XReffectivenessmethylphenidatemultiple-unit pellet systemtreatment experiencedtreatment naïveWeiss Functional Impairment Rating Scale

Identifiers

PMID39650201
PMCPMC11622117

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Registered trials

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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.