Transcript A randomized controlled trial of citalopram on migraine

A randomized controlled trial of
citalopram on migraine
frequency
Satnam S. Nijjar, M.D.
Department of Neurology,
Johns Hopkins School of Medicine
Burden of Migraine
Migraine is highly prevalent: 7.8 % in
males and 24.9% in females
Migraine has significant impact on the
sufferer and on society
Estimated cost of $13 billion/year in U.S.
– Absenteeism
– Reduced effectiveness
Need for improved prophylaxis
No clear first line therapy.
Decreased serotonin levels implicated,
however little evidence to support
selective serotonin reuptake inhibitors.
Citalopram is a well established SSRI with
a well known safety profile.
Hypothesis
Citalopram will significantly reduce the
frequency of episodic migraine compared
to placebo in patients who are candidates
for migraine prophylaxis.
Study Design
Randomization
Citalopram 20 mg daily
Placebo
consent and
initial intake
1 month
= Data Visit
3 months
6 months (primary
outcomes)
Study Population
Inclusion criteria
– Episodic migraine as defined by International
Headache Society
– Candidates for prophylaxis, not on previous treatment
Exclusion criteria
– chronic migraine
– analgesic overuse
– antidepressant therapy
Recruitment
– Approximately 100 adult patients
– Headache Clinic – Johns Hopkins Bayview Medical
Center
Variables
Primary outcome: migraine frequency as
assessed by diary
Secondary outcomes:
– Disease specific: Migraine Disability
Assessment Scale (MIDAS) and Headache
Impact Test (HIT) survey scores
– Quality of Life: SF-36 survey scores
Safety variables
– Symptom questionnaire
Statistical Analysis
Intention to treat analysis
Analytic steps
– Calculate rates (episodes/month)
– Compare rates
Ratio of rates
Difference of rates
Significance
Demonstrating the effectiveness of
citalopram in migraine prophylaxis may
alter current practice
Providing clinicians with a new avenue of
migraine treatment with a low side effect
profile.
Acknowledgements
Group Instructors:
– Dr. Larry Appel
– Dr. Liz Selvin
– Dr. Mark Woodward
Group Members:
– Dr. Liudmila Cebotaru, Dr. Ralph Daher, Dr.
Andrea Dugas, Dr. Christopher Ennen, Dr.
Shannon Haley, and Dr. Milap Nowrangi
Thank
you