SchizophreniaPhase 1NCT02176044
The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
A Phase 1 study testing Sodium Nitroprusside infusion in people with Schizophrenia, run by King's College London at 1 site in United Kingdom.
Trial summary
Spatial working memory (ability to remember where objects are in space) is impaired in patients with schizophrenia. It is thought that this impairment occurs due to problems with the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA) glutamate receptor, particularly in the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sodium Nitroprusside infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Feb 2016
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a diagnosis of schizophrenia or schizoaffective disorder, currently experiencing an exacerbation of symptoms (a score > 20 for PANSS-Positive subscale), currently taking antipsychotics and who have given informed consent to participate.
Who cannot join
- History of hypertension or current resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. Relevant medical illness (renal, hepatic, cardiac), prior history of intolerance to sodium nitroprusside, presence of a seizure disorder, any change in psychotropic medication in previous 6 weeks, diagnosis of substance abuse, pregnancy (as determined by urine test) or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, King's College Hospital
London, SE5
About this study
Spatial working memory (ability to remember where objects are in space) is impaired in patients with schizophrenia. It is thought that this impairment occurs due to problems with the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA) glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA receptor function would therefore be predicted to lead to reductions in Nitric Oxide production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative symptoms). In this study, the investigators will test the hypothesis that sodium nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their performance on a spatial working memory task will be tested before and after administration of sodium nitroprusside or placebo.
- Conditions
- Schizophrenia
- Being tested
- Sodium Nitroprusside infusion, Placebo
- Keywords
- Nitric Oxide, Sodium Nitroprusside, Spatial Working Memory, Psychosis, Schizophrenia
- 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.
Sodium Nitroprusside infusionDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Glucose infusion | Placebo comparator | Placebo infusion of sterile 5% glucose - 500ml infused over 4 hours. Receives: Other: Placebo |
| Sodium Nitroprusside infusion | Active comparator | Sodium nitroprusside dissolved in 5% glucose solution. Infused at 0.5mcg/kg/min for 4 hours. Receives: Drug: Sodium Nitroprusside infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Working Memory
performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task
Measured: 4 hours post-infusion
Secondary outcomes (7)
Positive and Negative Syndrome Scale (PANSS)
Symptoms rated on PANSS
Measured: 4 hours post-infusion
Brief Psychiatric Rating Scale (BPRS)
Symptoms rated on BPRS
Measured: 4 hours post-infusion
Quick Inventory of Depressive Symptomatology (QIDS)
Symptoms rated on QIDS
Measured: 4 hours post-infusion
Hypomania Checklist (HCL-32)
Rating of symptoms on HCL-32
Measured: 4 hours post-infusion
Blood pressure
Measurement of blood pressure.
Measured: 4 hours post-infusion
Heart rate
Heart rate change from baseline
Measured: 4 hours post-infusion
Respiratory rate
change in respiratory rate from baseline.
Measured: 4 hours post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Stone, MBBS PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176044
- Sponsor's protocol ID
- NOSMEM01
- Status last verified
- Mar 2016
- First submitted
- 25 Jun 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stone JM, Morrison PD, Koychev I, Gao F, Reilly TJ, Kolanko M, Mohammadinasab A, Kapur S, McGuire PK. The effect of sodium nitroprusside on psychotic symptoms and spatial working memory in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. Psychol Med. 2016 Dec;46(16):3443-3450. doi: 10.1017/S0033291716002245. Epub 2016 Sep 22.
PubMed 27655012
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
- ClinicalTrials.gov ID
- NCT02176044
- Acronym / sponsor ID
- NOSMEM01
- Conditions
- Schizophrenia
- Keywords
- Nitric Oxide, Sodium Nitroprusside, Spatial Working Memory, Psychosis, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jun 2014 (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.
Spatial working memory (ability to remember where objects are in space) is impaired in patients with schizophrenia. It is thought that this impairment occurs due to problems with the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA) glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA receptor function would therefore be predicted to lead to reductions in Nitric Oxide production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative symptoms). In this study, the investigators will test the hypothesis that sodium nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their performance on a spatial working memory task will be tested before and after administration of sodium nitroprusside or placebo.
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 |
|---|---|---|
| Glucose infusion | Placebo comparator | Other: PlaceboPlacebo infusion of sterile 5% glucose - 500ml infused over 4 hours. |
| Sodium Nitroprusside infusion | Active comparator | Drug: Sodium Nitroprusside infusionSodium nitroprusside dissolved in 5% glucose solution. Infused at 0.5mcg/kg/min for 4 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of schizophrenia or schizoaffective disorder, currently experiencing an exacerbation of symptoms (a score > 20 for PANSS-Positive subscale), currently taking antipsychotics and who have given informed consent to participate.
Key exclusion criteria (1 listed)
- History of hypertension or current resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. Relevant medical illness (renal, hepatic, cardiac), prior history of intolerance to sodium nitroprusside, presence of a seizure disorder, any change in psychotropic medication in previous 6 weeks, diagnosis of substance abuse, pregnancy (as determined by urine test) or breastfeeding.
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 |
|---|---|---|
| Sodium Nitroprusside infusion | Drug | Sodium Nitroprusside infusion |
| Placebo | Other | Glucose infusion |
Primary outcome
Spatial Working Memory
Time frame: 4 hours post-infusion
performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task
7 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: 4 hours post-infusion
Brief Psychiatric Rating Scale (BPRS)
Time frame: 4 hours post-infusion
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: 4 hours post-infusion
Hypomania Checklist (HCL-32)
Time frame: 4 hours post-infusion
Blood pressure
Time frame: 4 hours post-infusion
Heart rate
Time frame: 4 hours post-infusion
Respiratory rate
Time frame: 4 hours post-infusion
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 9 Mar 2016.
- Derived from this study: PubMed 27655012Stone JM, Morrison PD, Koychev I, Gao F, Reilly TJ, Kolanko M, Mohammadinasab A, Kapur S, McGuire PK. The effect of sodium nitroprusside on psychotic symptoms and spatial working memory in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial. Psychol Med. 2016 Dec;46(16):3443-3450. doi: 10.1017/S0033291716002245. Epub 2016 Sep 22.
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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.
James Stone, MBBS PhD 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 Phase 1 study testing Sodium Nitroprusside infusion in people with Schizophrenia, 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 1 inclusion and 1 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 9 Mar 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Spatial Working Memory (time frame: 4 hours post-infusion). 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 NCT02176044, 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 9 Mar 2016.