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THIS STUDY IS NOW CLOSED SINCE NOV 2006
Please note that this study is now closed. Nonetheless, we will leave the site running for historical purposes, and will leave a link to the study results when they become published.
To all those youth and families that participated in the study, and who made a difference in helping us learn more about the treatment of depression, we sincerely thank you!
Study Information for Youth,
Families and Health Care Providers
We are looking for participants in a treatment study for
teenagers with major depression. The official study title
is: “A Double Blind Placebo Controlled Discontinuation Study
of Citalopram in Adolescents with Depression.”
Major depression is a serious condition that affects all
ages, and affects a large proportion of teenagers. Typical
symptoms include problems with mood, and physical complaints
such as problems with sleep, energy, appetite and concentration.
Fortunately, there are numerous effective treatments for depression.
These include various types of counseling, psychotherapy (e.g.
cognitive behavioral therapy, interpersonal therapy), and
in certain cases, medications may also be helpful.
This study is a multi-center clinical trial at various hospitals
throughout Canada , funded by a grant from the Canadian Institute
of Health Research (CIHR). Study personnel at CHEO include
Dr's Armand Boisjoli, Michael Cheng, Hazen Gandy and Derek
Puddester , as well as our study coordinator, Risa Mallory.
The lead principal investigator is Dr. Anthony Levitt , at
the Sunnybrook Health Sciences Centre in Toronto (see their
site www.moodtreatment.com
for more details.)
The purpose of our study is to look at the effectiveness
and safety of an antidepressant medication that is commonly
used in adults, and to see whether or not there is any benefit
to continuing to take antidepressant treatment after recovery
from depression.
Health Canada
Advisory. There have been reports that medications
in the same class (i.e. selective serotonin reuptake inhibitors)
may be associated with an increased risk of self-harm or suicidal
ideas and attempts. Health Canada has issued an advisory that
people under 18 taking antidepressants such as citalopram
(tradename Celexa) should consult their treating physician
to confirm that the benefits of the drug still outweigh the
potential risks. The risk of the new onset of suicidal thoughts
or attempts in some studies is in the range of 1 in 100 to
2 in 100 people treated. In children and adolescents other
antidepressant which affect the serotonin system may also
cause an increase in agitation, occurring in 10-25% of people.
At this time, it is still not clear whether or not these thoughts
are due to the treatment, or some other factor, e.g. the underlying
depression that was being treated.
Screening assessment: Prior to entering the study, potential
participants will undergo an assessment to see if they would
be eligible.
Eligible participants would be:
- Aged 13-18
- Having symptoms of major depression, which would mean:
- Five or more of the following symptoms during the
same two-week period, which are a change from previous
functioning, which might include:
- Troubles sleeping
- Troubles with appetite
- Troubles with low energy
- Problems with low self-esteem or guilt
- Loss of pleasure or enjoyment, or loss of interests
in activities
- Recurrent thoughts of suicide
Participants would NOT be eligible if they:
- Have had past treatment with Citalopram (Celexa)
- Have had past or present hypomanic or manic episode(s)
- Are having active symptoms of psychosis such as hallucinations
or delusions
- Are having significant problems with alcohol or street
drug use
- Are currently pregnant
Eligible participants would qualify for the depression
study, which would consist of the following:
- First (Acute, Active) Phase -- In the initial phase, lasting
up to 12-weeks (3-months), all eligible depressed adolescents
will receive treatment with the medication citalopram (tradename
Celexa), in combination with clinical monitoring which may
possibly include counselling/psychotherapy.
Patients will be seen every 2 weeks during this first phase,
lasting up to 3 months.
Patients who have not improved sufficiently during this
phase will be withdrawn from the study, and we will help
find appropriate, alternative treatment.
- Second (Continuation) Phase – Participants whose depression
has improved will enter a continuation phase for 6 months.
Half of these adolescents will be given continued treatment
with the antidepressant citalopram, and the other half will
receive a placebo medication. A placebo medication is an
inert, inactive substance that has no effect. By doing so,
this will help us ascertain whether or not it is helpful
to continue taking antidepressant medication after one's
depression has improved.
Patients will be seen every 2 weeks for the first 2 months,
and then once monthly thereafter up until 6 months.
Patients who worsen during this phase will be withdrawn
from the study, and in deciding together along with their
study physician, they can then be restarted on treatment.
Medications will be provided by the study. In addition, during
the continuation phase of the study, participants will receive
approximately $10.00 for each visit attended in order to offset
any study-related expenses.
Studies in children and youth have shown that within about
12 weeks, antidepressant medication like citalopram can be
helpful (Wagner et al.: Efficacy of sertraline in the treatment
of children and adolescents with major depressive disorder.
JAMA 2003; 290:1033-1041; Emslie et al.: A double-blind, randomized,
placebo-controlled trial of fluoxetine in children and adolescents
with depression. Archives of General Psychiatry, 1997; 54(11):
1031-7).
However, after someone gets well, we still do not know how
long they should continue to take their medication -- this
is the main question that our research study attempts to answer.
Additional benefits for participants in the study include:
everyone will receive treatment for their depression, as well
as the knowledge that their participation is helping us to
learn how to help other teenagers with depression.
If you are a health care provider:
- Feel free to post our recruitment
poster in your office or contact Risa Mallory, 613-737-7600,
ext. 3673 for color copies
- Contact Dr. Michael Cheng, 613-738-6990, ext. 247 to discuss
the possibility of referring your patient for our study
If you are a youth or family member:
- Please leave a voicemail with our Project Coordinator,
Risa Mallory, 613-737-7600, ext. 3673, with a number where
you can be reached during the daytime or evening
- Feel free to print out and read our recruitment
letter
Other treatment for depression
For those who do not qualify for our study, or for those
with whom medication treatment would not be appropriate,
please click here for other ways to get help in Ottawa.
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