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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: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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:
Patients may receive adjunctive TCA treatment during the study at the clinician's discretion.
United States, North Carolina | |
Child and Adolescent Psychiatry Trials Network (CAPTN) | |
Durham, North Carolina, United States, 27715 |
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 MH066386, DSIR CTM, 3159; 8067-06-1 |
Study First Received: | October 31, 2006 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00395213 History of Changes |
Health Authority: | United States: Federal Government |
Anxiety Major Depression Anorexia Bulimia |
OCD Antidepressant SSRI SNRI |
Neurotransmitter Agents Adrenergic alpha-Agonists Depression Adrenergic Agents Psychotropic Drugs Cardiovascular Agents Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Adrenergic Agonists Serotonin Behavioral Symptoms |
Anxiety Disorders Mental Disorders Norepinephrine Bulimia Vasoconstrictor Agents Anorexia Mood Disorders Peripheral Nervous System Agents Obsessive-Compulsive Disorder Eating Disorders Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Adrenergic Agonists Pathologic Processes Mental Disorders Therapeutic Uses Vasoconstrictor Agents Antidepressive Agents Obsessive-Compulsive Disorder Eating Disorders Disease |
Depression Adrenergic alpha-Agonists Sympathomimetics Cardiovascular Agents Depressive Disorder Serotonin Uptake Inhibitors Serotonin Pharmacologic Actions Behavioral Symptoms Serotonin Agents Anxiety Disorders Autonomic Agents Norepinephrine Mood Disorders Peripheral Nervous System Agents |