The Treatment of Children and Adolescents With Treatment-Resistant Depression
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|ClinicalTrials.gov Identifier: NCT00029640|
Recruitment Status : Completed
First Posted : January 17, 2002
Last Update Posted : March 4, 2008
|Condition or disease|
The participants may or may not have taken a selective serotonin reuptake inhibitor (SSRI) (such as paroxetine (Paxil), sertraline (Zoloft) or fluoxetine (Prozac)) to treat their depression.
The participants and their parents are interviewed both individually and together with questions about the child's general mood, degree of nervousness, and behavior and how family members are doing. Children and adolescents will have a physical examination, blood tests, and intelligence and memory evaluations. Tests include standardized questions and tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices. Participants spend time in a, mock MRI scanner, to become comfortable with the procedure. Participants and their parents meet weekly for 2 weeks with a psychologist or psychiatrist for sessions. Those who remain depressed after these two sessions will begin study medication.
Those who are not currently taking an SSRI will be offered paroxetine. Those already taking an SSRI will be randomly assigned to receive either lithium or a placebo (non-active pill) in addition to the SSRI. Treatment continues for 8 weeks. During this time, the participant and parent meet with the doctor once a week and complete written and oral evaluations. Blood will be drawn before medication begins and at the end of the 8-week treatment. Participants will have additional blood taken after 1 week on medication to help in deciding whether dose adjustment is needed. Additional blood tests might be needed later on to ensure that the dose is correct. Those who improve after 8 weeks will continue treatment at NIH until responsibility for their care can be assume by an outside physician. Program staff will help in facilitating referrals to physicians who will monitor the medication after the child leaves the study.
|Study Type :||Observational|
|Enrollment :||90 participants|
|Official Title:||Clinical and Neurochemical Effects of Pharmacologic Treatment in Pediatric Depression|
|Study Start Date :||January 2002|
|Study Completion Date :||March 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029640
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|