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Completed

NCT Number: NCT02176044

The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Facility, King's College Hospital

London, SE5, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium nitroprusside infusion

Drug

Placebo

Other

Primary outcomes

  1. Spatial Working Memory

    Time frame: 4 hours post-infusion

    performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: 4 hours post-infusion

    Symptoms rated on PANSS

  2. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 4 hours post-infusion

    Symptoms rated on BPRS

  3. Quick Inventory of Depressive Symptomatology (QIDS)

    Time frame: 4 hours post-infusion

    Symptoms rated on QIDS

  4. Hypomania Checklist (HCL-32)

    Time frame: 4 hours post-infusion

    Rating of symptoms on HCL-32

  5. Blood pressure

    Time frame: 4 hours post-infusion

    Measurement of blood pressure.

  6. Heart rate

    Time frame: 4 hours post-infusion

    Heart rate change from baseline

  7. Respiratory rate

    Time frame: 4 hours post-infusion

    change in respiratory rate from baseline.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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