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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
Sponsor:
Information provided by (Responsible Party):
King's College London

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Sodium Nitroprusside infusion Other: Placebo Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Glucose infusion
Placebo infusion of sterile 5% glucose - 500ml infused over 4 hours.
 Other: Placebo
Active Comparator: Sodium Nitroprusside infusion
Sodium nitroprusside dissolved in 5% glucose solution. Infused at 0.5mcg/kg/min for 4 hours.
 Drug: Sodium Nitroprusside infusion


Outcome Measures
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Primary Outcome Measures :
  1. Spatial Working Memory [ Time Frame: 4 hours post-infusion ]
    performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United Kingdom
Clinical Research Facility, King's College Hospital
London, United Kingdom, SE5
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: James Stone, MBBS PhD King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02176044     History of Changes
Other Study ID Numbers: NOSMEM01
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by King's College London:
Nitric Oxide
Sodium Nitroprusside
Spatial Working Memory
Psychosis
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Nitric Oxide
Nitroprusside
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
 Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Antihypertensive Agents
Nitric Oxide Donors