The Role of Nitric Oxide in Cognition in Schizophrenia
NOC
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 15, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 13, 2019
March 1, 2018
2.6 years
September 15, 2016
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
The Bond-Lader Visual Analog Scales
Change from baseline to Day1, Day 2, Day 3, Day 7
Study Arms (2)
Glyceryl Trinitrate
EXPERIMENTALGlyceryl Trinitrate, sublingual spray, 3 x 0.4mg dose, once per day for 3 days in total.
Placebo
PLACEBO COMPARATORThe formulation composition of the placebo will be the same as the active spray minus the Glyceryl Trinitrate.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major physical illness
- Prior history of intolerance to glyceryl trinitrate
- Homicidal or suicidal
- Pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South London and Maudsley
London, SW9 9NT, United Kingdom
Related Publications (1)
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.
PMID: 32436761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Morrison, MRCPsych
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2016
First Posted
September 20, 2016
Study Start
September 1, 2016
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 13, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share