Summary:
Your participation in this research study will last approximately 21 weeks. This will include approximately 1 week of screening to make sure that you are right for the study. If you are eligible to take part, you will enter the study and will receive 16 weeks of treatment with either the investigational medication or placebo. The treatment you get will be decided by chance (like flipping a coin) but neither you nor your doctor will know which you are receiving. At the end of the 16 weeks you will stop taking the investigational medication and will be followed up for a further 4 weeks. However you will still continue your treatment with an SSRI throughout the study as prescribed by your doctor.
During the study, you will be asked to attend the clinic a total of 9 times and will have three telephone interviews. During study visits, you will be assessed for changes in your health and changes in your obsessive compulsive symptoms.
Clinical studies always involve a certain amount of commitment from the participants.
Each visit consists of a number of procedures so it is difficult to estimate the time that will be needed. You will be informed of your next scheduled study visit before leaving the study site.
The standard tests that will be performed during study visits are listed below. However, not every test will be performed at every visit. The study doctor will discuss what will happen at each study visit.
General health assessments include: e.g. measurement of height, weight, pulse rate, blood pressure
Urine/Blood tests: these tests assess your general state of health through the study as well as measuring the level of investigational medication in your body
Assessment of symptoms: You will be asked about how you are managing day-to-day activities
There may also be some risks and a certain level of discomfort in some of the procedures that are required. As with all medications, side effects can occur with investigational medication too. The study doctor will discuss these with you.
You may or may not benefit by participating in the SkyLyte study. However, by taking part, you could contribute to research that may help others experiencing obsessive compulsive symptoms in the future. You will receive study-related monitoring. During the study period you will be seen by a team of experienced doctors and nurses. Qualified participants will not be charged for study medications or study related medical care.
Qualified Participants Must:
• Be between 18 and 65 years of age
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Currently take medication for OCD
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Continue to have symptoms of OCD while on medication
Qualified Participants May Receive:
Study related procedures, study medication at no charge and $50 per each visit (total 9 visits).