The Role of Nitric Oxide in Cognition in Schizophrenia

Schizophrenia Clinical Trial

— NOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906553
• Other study ID #: 16/LO/1102
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Glyceryl Trinitrate

• Placebo

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The emotionally salient version of the Jumping to Conclusions (JTC) task		Change in performance from baseline to Day1, Day 2, Day 3, Day 7
Secondary	The Hopkins Verbal Learning Task - Revised, immediate recall		Change from baseline to Day1, Day 2, Day 3, Day 7
Secondary	Positive and negative syndrome scale (PANSS) (videotaped)		Change from baseline to Day1, Day 2, Day 3, Day 7
Secondary	The Bond-Lader Visual Analog Scales		Change from baseline to Day1, Day 2, Day 3, Day 7