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

August 12, 2019 updated by: King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW9 9NT
        • South London and Maudsley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change in performance from baseline to Day1, Day 2, Day 3, Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

South London and Maudsley NHS Foundation Trust

Investigators

  • Principal Investigator: Paul Morrison, MRCPsych, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/LO/1102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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