Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glyceryl Trinitrate | Experimental | Glyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total. |
|
| Placebo | Placebo Comparator | The formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glyceryl Trinitrate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The emotionally salient version of the Jumping to Conclusions (JTC) task | Change in performance from baseline to Day1, Day 2, Day 3, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The Hopkins Verbal Learning Task - Revised, immediate recall | Change from baseline to Day1, Day 2, Day 3, Day 7 | |
| Positive and negative syndrome scale (PANSS) (videotaped) | Change from baseline to Day1, Day 2, Day 3, Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Morrison, MRCPsych | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley | London | SW9 9NT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32436761 | Derived | Merritt K, Catalan A, Cowley S, Demjaha A, Taylor M, McGuire P, Cooper R, Morrison P. Glyceryl trinitrate in first-episode psychosis unmedicated with antipsychotics: A randomised controlled pilot study. J Psychopharmacol. 2020 Aug;34(8):839-847. doi: 10.1177/0269881120922967. Epub 2020 May 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| The Bond-Lader Visual Analog Scales | Change from baseline to Day1, Day 2, Day 3, Day 7 |