Schizophrenia Clinical Trial
— NOCOfficial title:
The Role of Nitric Oxide in Cognition in Schizophrenia; The NOC Study (Nitric Oxide in Cognition)
NCT number | NCT02906553 |
Other study ID # | 16/LO/1102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | April 2019 |
Verified date | March 2018 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | South London and Maudsley | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | South London and Maudsley NHS Foundation Trust |
United Kingdom,
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 |
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