SchizophreniaNOCNCT02906553
The Role of Nitric Oxide in Cognition in Schizophrenia
A study testing Glyceryl Trinitrate in people with Schizophrenia and Psychotic Disorders, run by King's College London at 1 site in United Kingdom.
Trial summary
This study evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Glyceryl Trinitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Apr 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years of age
- Patients undergoing an acute psychotic episode (defined as score > 4 on question P1 of the PANSS positive subscale) requiring full-time hospitalisation according to clinical referral by the relevant mental health service
- Demonstrates capacity and willing to give informed consent
- Female participants willing to have a pregnancy test before treatment
- Currently unmedicated with antipsychotic medication
Who cannot join
- Major physical illness
- Prior history of intolerance to glyceryl trinitrate
- Homicidal or suicidal
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Nitric Oxide in Cognition in Schizophrenia; The NOC Study (Nitric Oxide in Cognition)
This study evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed.
Read the detailed description
Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is integrated with the glutamate system. Glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO system, as glutamate receptors signal by way of NO.
Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry.
The primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Glyceryl Trinitrate, Placebo
- Keywords
- Nitric Oxide, Cognition
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl TrinitrateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Glyceryl Trinitrate | Experimental | Glyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total. Receives: Drug: Glyceryl Trinitrate |
| Placebo | Placebo comparator | The formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The emotionally salient version of the Jumping to Conclusions (JTC) task
Measured: Change in performance from baseline to Day1, Day 2, Day 3, Day 7
Secondary outcomes (3)
The Hopkins Verbal Learning Task - Revised, immediate recall
Measured: Change from baseline to Day1, Day 2, Day 3, Day 7
Positive and negative syndrome scale (PANSS) (videotaped)
Measured: Change from baseline to Day1, Day 2, Day 3, Day 7
The Bond-Lader Visual Analog Scales
Measured: Change from baseline to Day1, Day 2, Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Paul Morrison, MRCPsych, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906553
- Sponsor's protocol ID
- 16/LO/1102
- Acronym
- NOC
- Status last verified
- Mar 2018
- First submitted
- 15 Sep 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Merritt K, Catalan A, Cowley S, Demjaha A, Taylor M, McGuire P, Cooper R, Morrison P. Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study. J Psychopharmacol. 2020 Aug;34(8):839-847. doi: 10.1177/0269881120922967. Epub 2020 May 21.
PubMed 32436761
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nitric Oxide in Cognition in Schizophrenia; The NOC Study (Nitric Oxide in Cognition)
- ClinicalTrials.gov ID
- NCT02906553
- Acronym / sponsor ID
- NOC / 16/LO/1102
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Nitric Oxide, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Sep 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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 evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed.
Detailed description
Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is integrated with the glutamate system. Glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO system, as glutamate receptors signal by way of NO.
Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry.
The primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyceryl Trinitrate | Experimental | Drug: Glyceryl TrinitrateGlyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total. |
| Placebo | Placebo comparator | Drug: PlaceboThe formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-40 years of age
- Patients undergoing an acute psychotic episode (defined as score > 4 on question P1 of the PANSS positive subscale) requiring full-time hospitalisation according to clinical referral by the relevant mental health service
- Demonstrates capacity and willing to give informed consent
- Female participants willing to have a pregnancy test before treatment
- Currently unmedicated with antipsychotic medication
Key exclusion criteria (4 listed)
- Major physical illness
- Prior history of intolerance to glyceryl trinitrate
- Homicidal or suicidal
- Pregnant or breast feeding
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 |
|---|---|---|
| Glyceryl Trinitrate | Drug | Glyceryl Trinitrate |
| Placebo | Drug | Placebo |
Primary outcome
The emotionally salient version of the Jumping to Conclusions (JTC) task
Time frame: Change in performance from baseline to Day1, Day 2, Day 3, Day 7
3 secondary outcomes
The Hopkins Verbal Learning Task - Revised, immediate recall
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
Positive and negative syndrome scale (PANSS) (videotaped)
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
The Bond-Lader Visual Analog Scales
Time frame: Change from baseline to Day1, Day 2, Day 3, Day 7
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 13 Aug 2019.
- Derived from this study: PubMed 32436761Merritt K, Catalan A, Cowley S, Demjaha A, Taylor M, McGuire P, Cooper R, Morrison P. Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study. J Psychopharmacol. 2020 Aug;34(8):839-847. doi: 10.1177/0269881120922967. Epub 2020 May 21.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Paul Morrison, MRCPsych principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyceryl Trinitrate in people with Schizophrenia and Psychotic Disorders, 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 5 inclusion and 4 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 13 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
The emotionally salient version of the Jumping to Conclusions (JTC) task (time frame: Change in performance from baseline to Day1, Day 2, Day 3, Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906553, which also lists 1 linked publication.
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 13 Aug 2019.