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The Role of Nitric Oxide in Cognition in Schizophrenia (NOC)

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ClinicalTrials.gov Identifier: NCT02906553
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:
This study evaluates the role of the Nitric Oxide system in cognition in patients with schizophrenia. Participants will be randomised to 2 equal groups and receive either the Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several cognitive tasks will be assessed.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Drug: Glyceryl Trinitrate Drug: Placebo Not Applicable

Detailed Description:

Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is integrated with the glutamate system. Glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO system, as glutamate receptors signal by way of NO.

Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry.

The primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of Nitric Oxide in Cognition in Schizophrenia; The NOC Study (Nitric Oxide in Cognition)
Study Start Date : September 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Glyceryl Trinitrate
Glyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total.
Drug: Glyceryl Trinitrate
Placebo Comparator: Placebo
The formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate.
Drug: Placebo



Primary Outcome Measures :
  1. The emotionally salient version of the Jumping to Conclusions (JTC) task [ Time Frame: Change in performance from baseline to Day1, Day 2, Day 3, Day 7 ]

Secondary Outcome Measures :
  1. The Hopkins Verbal Learning Task - Revised, immediate recall [ Time Frame: Change from baseline to Day1, Day 2, Day 3, Day 7 ]
  2. Positive and negative syndrome scale (PANSS) (videotaped) [ Time Frame: Change from baseline to Day1, Day 2, Day 3, Day 7 ]
  3. The Bond-Lader Visual Analog Scales [ Time Frame: Change from baseline to Day1, Day 2, Day 3, Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 years of age
  • Patients undergoing an acute psychotic episode (defined as score > 4 on question P1 of the PANSS positive subscale) requiring full-time hospitalisation according to clinical referral by the relevant mental health service
  • Demonstrates capacity and willing to give informed consent
  • Female participants willing to have a pregnancy test before treatment
  • Currently unmedicated with antipsychotic medication

Exclusion Criteria:

  • Major physical illness
  • Prior history of intolerance to glyceryl trinitrate
  • Homicidal or suicidal
  • Pregnant or breast feeding

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): NCT02906553


Contacts
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Contact: Kate S Merritt, PhD 0207 848 0165 kate.merritt@kcl.ac.uk
Contact: Ruth Cooper, PhD 02075404380 ext 2344 Ruth.Cooper1@elft.nhs.uk

Locations
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United Kingdom
South London and Maudsley Recruiting
London, United Kingdom, SW9 9NT
Contact: Matthew Taylor       matthew.taylor@slam.nhs.uk   
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
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Principal Investigator: Paul Morrison, MRCPsych King's College London

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02906553     History of Changes
Other Study ID Numbers: 16/LO/1102
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by King's College London:
Nitric Oxide
Cognition

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Nitric Oxide
Nitroglycerin
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