Effect of Roflumilast on cognitive function in schizophrenia
A Randomized, Double-Blind, Placebo Controlled, 3-period, Proof of Mechanism, Cross-Over Study of Roflumilast (250 or 500 µg) Administered up to Steady State to Evaluate the Effects of Add-on Roflumilast to Second Generation Antipsychotics on Cognitive Impairment as well as Brain Imaging (ie, fMRI) and Electrical Activity (ie, EEG) Changes Observed in Subjects With Stable Schizophrenia
Nycomed Danmark Aps
Schizophrenia is a chronic, mental disorder that affects about 1 percent of people throughout the world. It typically begins in early adulthood. It can cause hallucinations, delusions and cognitive performance may be affected (in particular memory, concentration, ability to make plans and develop strategies, or even just doing day-to-day activities). It is thought that fluilast may improve the cognitive performance in people with Schizophrenia. This study is designed to investigate whether a short course (8 days) of fluilast can improve cognition. Fluilast is not a newly-developed drug; it is already used to reduce inflammation in people with breathing difficulties. Recent research has suggested fluilast may improve some mental processing abilities such as memory and mental flexibility. This study will involve up to 22 participants (men and women) aged 18-55 years old. All participants will take one of three capsules for 8 days in a row each - containing either a placebo tablet (a dummy medicine that looks identical but does not contain the drug), a low dose of fluilast, or a medium dose of fluilast. Tests performed through the study will include: blood and urine tests, measurement of vital signs (pulse, blood pressure) ECG (assessment of the heart??s electrical activity), â€œcognitiveâ€ tests (these are tests of mental processing such as of memory and concentration). During these tests EEG (electroencephalography which involves wearing a cap on the head which measures small signals of electrical activity on the scalp.) data will be collected. In addition volunteers will play some games (tests) in an MRI scanner (a machine that takes pictures of the brain). Taking part in the study involves making a total of 8 visits to the Institute of Psychiatry, spaced out with breaks, over a period of 11 weeks. Volunteers will be paid Å“800 compensation if they complete the full study.
South Central - Berkshire Research Ethics Committee
Date of REC Opinion
8 Oct 2012
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