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CompletedNCT07866833DREAMUpdated Oct 8, 2026

Dysfunction of Respiratory Enzymes in Adults With Mental Illness (DREAM)

An interventional study of Methylene Blue in Schizophrenia and Other Psychotic Disorders and Healthy Adult, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by King's College London · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 years 3 months after the study started (first participant enrolled Jun 2020, registered Sep 2026).
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study tested whether intravenous methylene blue changes brain activity during a working-memory task differently in adults with schizophrenia taking stable antipsychotic medication and healthy volunteers. Each participant received methylene blue and a placebo solution with no methylene blue at separate visits and completed the task during functional magnetic resonance imaging (fMRI)

02

Conditions studied

  • Schizophrenia and Other Psychotic Disorders
  • Healthy Adult

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03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 53 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

King's College London is the lead sponsor of 519 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Aged 18 to 65 years.
  • Able to provide informed consent and have an adequate command of English.
  • For participants in the schizophrenia group: diagnosis of schizophrenia according to DSM-5 criteria.
  • For control participants: no current or past mental disorder.
  • For control participants: no family history of schizophrenia or psychosis.
  • No history of head trauma resulting in loss of consciousness.
  • For female participants: negative pregnancy test.
  • No history of neurological disorder or past or present neurological illness.
  • No drug, alcohol, or substance dependence, except nicotine.
  • No significant medical or physical disorder or illness.
  • No contraindications to MRI.
  • Not currently breastfeeding.
  • No participation in a clinical trial or receipt of an investigational product within 90 days, five half-lives, or twice the duration of the biological effect of the investigational product, whichever is longer.
  • Negative blood test for glucose-6-phosphate dehydrogenase deficiency.
  • Not taking an SSRI, MAOI, or other serotonergic drug in the 6 weeks before the study.
  • No cardiac arrhythmia on screening ECG.
  • No history of renal failure.
  • No significant history of heart disease or ECG abnormality.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Placebo first drug second

    Placebo first drug second

    Drug: Methylene Blue

  • Experimental
    Drug first placebo second

    Drug first placebo second

    Drug: Methylene Blue

Interventions

06

What researchers measure

Primary outcomes

  1. FMRI BOLD response

    FMRI BOLD response during working memory task

    Time frame: Day 1 [on day of drug/placebo administration]

07

Study locations

1 site
  • Robert Steiner MRI Unit
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — only IPD used in the results publication

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866833
Responsible party
Ekaterina Shatalina (Lead Research Scientist, King's College London) — Principal investigator
First posted
Oct 8, 2026
Start date
Jun 1, 2020
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Methylene Blue

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