Evidence map›Paper›PMID 29121974›Full record

Trial reportTrials2017

A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol.

Inti Qurashi, Imran B Chaudhry, Ameer B Khoso, Sana Farooque, Steve Lane, Mohammad Omair Husain, Simon Chu, Jane Sarginson, Munir Hamarani, Haider A Naqvi and 5 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02569307 (A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States), which is not on this map. Cited by 11 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 5 pooled it
1.3field-weighted citation impact, top 20% of its field
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.

NCT02569307 phase2completednot on this map

A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States

TypeinterventionalSponsorPakistan Institute of Living and LearningRan2015 to 2019Enrolled326ConditionsAt Risk Mental State (ARMS), PsychosisArmsMinocycline, Omega-3 fatty acids, Placebo, Minocycline Plus Omega-3 fatty acids
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 5 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Interventions for prodromal stage of psychosis.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Article
  7. Article
  8. Article
  9. Add-on Sodium Benzoate andSchizophrenia bulletin open · 2024
    Article
  10. Review
  11. 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

15 authors at 7 institutions in 2 countries.

Inti QurashiAshworth Research Centre, Mersey Care NHS Foundation Trust, Maghull, UK.
Imran B ChaudhryFaculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Ameer B KhosoPakistan Institute of Living & Learning, Karachi, Pakistan.
Sana FarooquePakistan Institute of Living & Learning, Karachi, Pakistan.
Steve LaneInstitute of Translational Medicine, University of Liverpool, Liverpool, UK.
Mohammad Omair HusainManchester Mental Health and Social Care Trust, Manchester, UK.
Simon ChuAshworth Research Centre, Mersey Care NHS Foundation Trust, Maghull, UK. schu@uclan.ac.uk.ORCID http://orcid.org/0000-0001-8921-4942
Jane SarginsonFaculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Munir HamaraniAbbasi Shaheed Hospital, Karachi, Pakistan.
Haider A NaqviZiauddin University, Karachi, Pakistan.
Bushra RazzaqueInstitute of Psychiatry & WHO Collaborating Centre, Rawalpindi, Pakistan.
Fareed A MinhasInstitute of Psychiatry & WHO Collaborating Centre, Rawalpindi, Pakistan.
Alison R YungFaculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
J F W DeakinFaculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Nusrat HusainFaculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
University of Manchester · GBPakistan Institute of Learning and Living · PKRawalpindi Medical University · PKAbbasi Shaheed Hospital · PKUniversity of Lancashire · GBUniversity of Liverpool · GBZiauddin University · PK

Funding

Stanley Medical Research Institute 14T-003
6 · The paper itself

Abstract

backgroundThe at-risk mental state (ARMS) describes individuals at high risk of developing schizophrenia or psychosis. The use of antipsychotics in this population is not supported, because most individuals with ARMS are unlikely to develop psychosis. Anti-inflammatory treatments and polyunsaturated fatty acids (PUFAs) may have some beneficial effects in the treatment of ARMS. There have been no controlled clinical trials in which researchers have investigated the use of minocycline for ARMS and no trials involving PUFAs in combination with other proposed treatments. There is a need to find effective, tolerable and inexpensive interventions for individuals with ARMS that are available in high-, low- and middle-income countries. METHODS/

designA 6-month intervention study of minocycline and/or omega-3 fatty acids added to treatment as usual (TAU) in patients with ARMS will be conducted in Pakistan using a randomised, placebo-controlled, double-blind factorial design. A total of 320 consenting patients with capacity will be recruited from the community, general practitioner clinics and psychiatric units. Allowing for a 25% dropout rate, we will recruit 59 completing participants into each study arm, and in total 236 will complete the study. We will determine whether the addition of minocycline and/or omega-3 fatty acids to TAU attenuates the rate of transition from ARMS to first-episode psychosis and improves symptoms and/or level of functioning in ARMS. We will also investigate whether any candidate risk factors, such as negative symptoms, influence treatment response in the ARMS group. The primary efficacy endpoint is conversion to psychotic disorder at 12 months after study entry. Analysis will be done according to the intention to treat principle using analysis of variance, chi-square tests and adjusted ORs to assess between-group differences. Cox regression analysis will be used to evaluate potential between-group differences in time to onset of psychosis. DISCUSSION: The outcomes of this trial will provide evidence of the potential benefits of minocycline and PUFAs in the treatment of ARMS. Both minocycline and PUFAs are inexpensive, are readily available in low-/middle-income countries such as Pakistan, and if proven, may be safe and effective for treating individuals with ARMS.

trial registrationClinicalTrials.gov, NCT02569307 . Registered on 3 October 2015.

Indexed as

Dietary SupplementsMental HealthSchizophrenic PsychologyAdolescentAdultAnti-Inflammatory AgentsChi-Square DistributionClinical ProtocolsDouble-Blind MethodFatty Acids, Omega-3FemaleHumansIntention to Treat AnalysisMaleMinocyclinePakistanAnti-Inflammatory AgentsFatty Acids, Omega-3MinocyclineAt-risk mental state (ARMS)Global mental healthMinocyclineOmega-3 fatty acidsPUFAUltra-high risk (UHR) schizophrenia

Identifiers

PMID29121974
PMCPMC5679379
OpenAlexW2767938504

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.