The Role of Nitric Oxide in Cognition in Schizophrenia (NOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02906553|
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychotic Disorders||Drug: Glyceryl Trinitrate Drug: Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
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.
- 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 ]
- The Hopkins Verbal Learning Task - Revised, immediate recall [ Time Frame: 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 ]
- The Bond-Lader Visual Analog Scales [ Time Frame: Change from baseline to Day1, Day 2, Day 3, Day 7 ]
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
|South London and Maudsley|
|London, United Kingdom, SW9 9NT|
|Principal Investigator:||Paul Morrison, MRCPsych||King's College London|