Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00794040 |
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 2-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.
...
Condition | Intervention | Phase |
---|---|---|
Mood Disorder Mental Disorder Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorder Attention Deficit Hyperactivity Disorder |
Drug: Citalopram Drug: Methylphenidate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation |
Estimated Enrollment: | 80 |
Study Start Date: | November 2008 |
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 2-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.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
The child is failing his/her treatment. To meet this criterion:
i.The child's current CGAS score must be less than or equal to 60.
ii.The child's psychiatrist/treater must agree that the child's response to his/her current treatment is no more than minimal. According to this criterion, it would be clinically appropriate to change the child's current treatment.
iii.On the basis of record review and interviews with child and parent, the research team agrees that the child's response to his/her current treatment is no more than minimal.
iv.The child has a score of greater than 12 on the irritability subscale of the Aberrant Behavior Checklist.
EXCLUSION CRITERIA:
As assessed in the mania section of the K-SADS-PL, the individual exhibits any of these cardinal bipolar symptoms in distinct periods lasting more than 1 day, and therefore meets criteria for bipolar disorder not otherwise specified:
i) Elevated or expansive mood
ii) Grandiosity or inflated self-esteem
iii) Decreased need for sleep
iv) Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Ellen Leibenluft, M.D./National Institute of Mental Health ) |
Study ID Numbers: | 090034, 09-M-0034 |
Study First Received: | November 18, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00794040 |
Health Authority: | United States: Federal Government |
Irritability Attention Deficit Hyperactivity Disorder Explosive Tantrums Bipolar Mood Disorder |
Bipolar Disorder Attention Deficit and Disruptive Behavior Disorders Methylphenidate Dyskinesias Citalopram Serotonin Signs and Symptoms Dopamine |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Mood Disorders Hyperkinesis Neurologic Manifestations Dexetimide |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Central Nervous System Stimulants |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Pathologic Processes Therapeutic Uses Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |