Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
A Controlled Trial of Citalopram Added to Methylphenidate in Youth With Severe Mood Dysregulation
Severe mood dysregulation (SMD) is a very common syndrome in children. Its symptoms include
very severe irritability, including persistent anger and frequent outbursts, as well as
distractibility, hyperactivity, and other symptoms of attention deficit hyperactivity
disorder (ADHD). Many children with SMD receive the diagnosis of bipolar disorder (BD) in the
community, although they do not have clear manic episodes (with symptoms such as extreme
happiness and decreased need for sleep). Because SMD has not been studied in depth, we do not
know which medications are most helpful to those with SMD. This study will evaluate the
effectiveness of the stimulant medication methylphenidate (MPH, more commonly known as
Ritalin ) when combined (or not combined) with the antidepressant citalopram (Celexa ) in
treating symptoms of SMD in children and adolescents. This study will provide information
about how to treat SMD in youth.
This study will include approximately 80 patients between 7 and 17 years of age with SMD. The
patient s symptoms must have started before age 12.
The study will consist of four phases carried out over 4 to 5 months. During Phase 1, the
patient will undergo blood and urine tests, and will gradually taper off his or her
medication. The duration of this phase depends on the patient s medication before starting
the study. In Phase 2, the patient remains off all medication for 1 week. In Phase 3, the
patient will be treated with MPH for 2 weeks, and then will be randomly assigned to receive
either MPH plus citalopram or MPH plus a placebo for a further 8 weeks. In Phase 4, the
researchers will evaluate the effectiveness of the medications taken, and begin an open
treatment phase using medications that they deem appropriate for that patient (this may
include MPH with citalopram and/or other medication combinations).
Most patients will be admitted to the Pediatric Behavioral Health Unit at the National
Institutes of Health Clinical Center during the medication withdrawal part of the study
(Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or
in day treatment, depending on what is in his or her best interests.
...
Objective: To test the efficacy of citalopram plus methylphenidate vs. placebo plus
methylphenidate in decreasing irritability in youth with severe mood dysregulation.
Study population: Youth ages 7-17 with severe mood dysregulation (SMD). SMD is characterized
by nonepisodic, impairing irritability (defined as increased reactivity to negative emotional
stimuli at least 3 times/week and angry or sad mood, most days, most of the time, noticeable
to others) and hyperarousal (three of: distractibility, intrusiveness, pressured speech,
racing thoughts, agitation, insomnia), with onset before age 12. Many of these children
receive the diagnosis of bipolar disorder (BD) in the community, although they do not meet
DSM-IV criteria for BD because of the lack of distinct manic episodes.
Design: Medication withdrawal, followed by a 5-week dose stabilization phase of
methylphenidate and an 8-week double-blind, placebo-controlled treatment trial of citalopram
plus methylphenidate vs. placebo plus methylphenidate. There will also be optional open
treatment at the end, so that all patients have the opportunity to have a total of up to 10
weeks of citalopram plus methylphenidate. The target dose of citalopram will be 20-40 mg/day.
Outcome measures: The primary outcome measures will be the Aberrant Behavior Checklist
Irritability subscale and the CGI-I.
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