The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
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ClinicalTrials.gov Identifier: NCT02176044 |
Recruitment Status :
Completed
First Posted : June 26, 2014
Last Update Posted : March 9, 2016
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia | Drug: Sodium Nitroprusside infusion Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study |
Study Start Date : | August 2014 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Glucose infusion
Placebo infusion of sterile 5% glucose - 500ml infused over 4 hours.
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Other: Placebo |
Active Comparator: Sodium Nitroprusside infusion
Sodium nitroprusside dissolved in 5% glucose solution. Infused at 0.5mcg/kg/min for 4 hours.
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Drug: Sodium Nitroprusside infusion |
- Spatial Working Memory [ Time Frame: 4 hours post-infusion ]performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task
- Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 4 hours post-infusion ]Symptoms rated on PANSS
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 4 hours post-infusion ]Symptoms rated on BPRS
- Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 4 hours post-infusion ]Symptoms rated on QIDS
- Hypomania Checklist (HCL-32) [ Time Frame: 4 hours post-infusion ]Rating of symptoms on HCL-32
- Blood pressure [ Time Frame: 4 hours post-infusion ]Measurement of blood pressure.
- Heart rate [ Time Frame: 4 hours post-infusion ]Heart rate change from baseline
- Respiratory rate [ Time Frame: 4 hours post-infusion ]change in respiratory rate from baseline.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176044
United Kingdom | |
Clinical Research Facility, King's College Hospital | |
London, United Kingdom, SE5 |
Principal Investigator: | James Stone, MBBS PhD | King's College London |
Responsible Party: | King's College London |
ClinicalTrials.gov Identifier: | NCT02176044 |
Other Study ID Numbers: |
NOSMEM01 |
First Posted: | June 26, 2014 Key Record Dates |
Last Update Posted: | March 9, 2016 |
Last Verified: | March 2016 |
Nitric Oxide Sodium Nitroprusside Spatial Working Memory Psychosis Schizophrenia |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Nitroprusside |
Antihypertensive Agents Vasodilator Agents Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action |