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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

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE June 26, 2014
Last Update Posted Date March 9, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Spatial Working Memory [ Time Frame: 4 hours post-infusion ]
performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
Official Title  ICMJE The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Sodium Nitroprusside infusion
  • Other: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Glucose infusion
    Placebo infusion of sterile 5% glucose - 500ml infused over 4 hours.
    Intervention: Other: Placebo
  • Active Comparator: Sodium Nitroprusside infusion
    Sodium nitroprusside dissolved in 5% glucose solution. Infused at 0.5mcg/kg/min for 4 hours.
    Intervention: Drug: Sodium Nitroprusside infusion
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. Epub 2016 Sep 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2014)
30
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02176044
Other Study ID Numbers  ICMJE NOSMEM01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Stone, MBBS PhD King's College London
PRS Account King's College London
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP