be at least 18 years of age
The complete list of requirements will be
discussed with you by the study doctor.
During the first visit (the "screening visit"),
the study requirements as well as the
potential risks of participation will be
explained in detail. Those wishing to
participate after this explanation will be
asked to sign a written consent form. Next,
various questions, tests and examinations
will be asked and given to determine
eligibility to participate in the study.
be experiencing a depressive episode of at
least 8 weeks but less than 2 years in length
What are the potential benefits of
There may be potential risks to participating
in this study, which will be
discussed with you in detail at the start of the
study. All medication and some medical
procedures may carry a risk of side effects;
therefore, it is possible that participants may
experience some discomfort or other side
effects associated with the use of the study
medication. Study participants should report
any side effects to their study doctor or the
study doctor's staff.
For additional information, call Anne at IPC Research, 262-955-6515.
have a history of inadequate relief from
depression symptoms from 1 or 2
All medical examinations and study drug are
provided to qualified participants at no cost.
Financial compensation may be provided to
those who qualify for such compensation,
which will cover time and travel expenses
related to the research study.
Are there any risks to participating
in this research study?
What are the requirements to
participate in this research study?
All participants enrolled in this study will
first receive an FDA approved antidepressant
for a period of six weeks. Then, if eligible,
the participants will be assigned to one of two
groups. One group will begin taking the
investigational drug, and the other group will
continue taking the approved antidepressant.
This part of the study will continue for
another six weeks. The chance of being
assigned to either group is 50%, like flipping
Does it cost anything to participate?
To participate in this study,
There is no guarantee that participants will
receive any benefit from participating in the
study. Your depression might not get better
or may even get worse while you are in this
study. However, this research study may
yield new information that could benefit
patients with depression in the future by
helping to answer questions about the
effectiveness and safety of the
investigational depression medication.