Schizophrenia and Other Psychotic DisordersDREAMNCT07866833
Dysfunction of Respiratory Enzymes in Adults With Mental Illness (DREAM)
A study testing Methylene Blue in people with Schizophrenia and Other Psychotic Disorders and Healthy Adult, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Other Psychotic Disorders, Healthy Adult
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 31 Aug 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Mitochondrial Complex 1 (MC1) in Brain Dysfunction in Serious Mental Illness
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)
- Being tested
- Methylene Blue
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
methylene blue i.v. 0.5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Placebo first drug second | Experimental | Placebo first drug second Receives: Drug: Methylene Blue |
| Drug first placebo second | Experimental | Drug first placebo second Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRI BOLD response
FMRI BOLD response during working memory task
Measured: Day 1 [on day of drug/placebo administration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jun 2020
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Other Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Ekaterina Shatalina, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866833
- Sponsor's protocol ID
- 20/NS/0056
- Acronym
- DREAM
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mitochondrial Complex 1 (MC1) in Brain Dysfunction in Serious Mental Illness
- ClinicalTrials.gov ID
- NCT07866833
- Acronym / sponsor ID
- DREAM / 20/NS/0056
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Oct 2026 (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.
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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first drug second | Experimental | Drug: Methylene BluePlacebo first drug second |
| Drug first placebo second | Experimental | Drug: Methylene BlueDrug first placebo second |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Methylene Bluemethylene blue i.v. 0.5mg/kg | Drug | Drug first placebo second, Placebo first drug second |
Primary outcome
FMRI BOLD response
Time frame: Day 1 [on day of drug/placebo administration]
FMRI BOLD response during working memory task
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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 study testing Methylene Blue in people with Schizophrenia and Other Psychotic Disorders and Healthy Adult, run by King's College London at 1 site in United Kingdom.
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 18 inclusion and 0 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 8 Oct 2026. 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 United Kingdom. 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.
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?
FMRI BOLD response (time frame: Day 1 [on day of drug/placebo administration]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.