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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176044
• Other study ID #: NOSMEM01
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2014
• Last updated: March 8, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Sodium Nitroprusside infusion

Other:
• Placebo

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility, King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial Working Memory	performance on Cambridge Neuropsychological Test Automated Battery spatial working memory task	4 hours post-infusion	No
Secondary	Positive and Negative Syndrome Scale (PANSS)	Symptoms rated on PANSS	4 hours post-infusion	No
Secondary	Brief Psychiatric Rating Scale (BPRS)	Symptoms rated on BPRS	4 hours post-infusion	No
Secondary	Quick Inventory of Depressive Symptomatology (QIDS)	Symptoms rated on QIDS	4 hours post-infusion	No
Secondary	Hypomania Checklist (HCL-32)	Rating of symptoms on HCL-32	4 hours post-infusion	No
Secondary	Blood pressure	Measurement of blood pressure.	4 hours post-infusion	Yes
Secondary	Heart rate	Heart rate change from baseline	4 hours post-infusion	Yes
Secondary	Respiratory rate	change in respiratory rate from baseline.	4 hours post-infusion	Yes