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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00395213 |
This study will evaluate the risks and benefits of treatment with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder.
Condition | Intervention | Phase |
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Anxiety Disorders Depressive Disorders Eating Disorders Obsessive Compulsive Disorder |
Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Antidepressant Safety in Kids (ASK) Study: An Open-Label, Prospective, Cohort Study of Antidepressants in Children and Adolescents With Anxiety Disorders, Depressive Disorders, Eating Disorders, or Obsessive-Compulsive Disorder |
Estimated Enrollment: | 2420 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | February 2010 |
Groups/Cohorts | Assigned Interventions |
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1
Children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
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Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications
Treatment with SSRIs or SNRIs
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Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Children and adolescents age 7 to 17 years old.
Inclusion Criteria:
Exclusion Criteria:
Contact: Jerry L. Kirchner, BS | 919-668-7818 | jerry.kirchner@duke.edu |
Contact: John S. March, MD, MPH | 919-416-2404 | jsmarch@acpub.duke.edu |
United States, North Carolina | |
Child and Adolescent Psychiatry Trials Network (CAPTN) | Recruiting |
Durham, North Carolina, United States, 27715 | |
Contact: Jerry L. Kirchner, BS 919-668-7818 jerry.kirchner@duke.edu | |
Contact: John S. March, MD, MPH 919-416-2404 jsmarch@duke.edu | |
Principal Investigator: John S. March, MD, MPH |
Principal Investigator: | John S. March, MD, MPH | Duke University School of Medicine |
Responsible Party: | Duke University Medical Center ( John S. March, MD, MPH ) |
Study ID Numbers: | P30 MH66386, DSIR CTM, 3159; 8067-06-1 |
Study First Received: | October 31, 2006 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00395213 |
Health Authority: | United States: Federal Government |
Anxiety Major Depression Anorexia Bulimia |
OCD Antidepressant SSRI SNRI |
Depression Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms Anxiety Disorders Mental Disorders |
Bulimia Norepinephrine Anorexia Mood Disorders Obsessive-Compulsive Disorder Eating Disorders |
Neurotransmitter Agents Disease Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Adrenergic Agonists Pharmacologic Actions Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents |