Antidepressant Safety in Kids Study

NCT00395213 | Completed DMC

• 4 other identifiers: Pro00013655P30MH066386DSIR CTM3159; 8067-06-1
• Study Type: observational
• Target: 569
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders; Depressive Disorders; Eating Disorders; Obsessive Compulsive Disorder

Keywords

Anxiety; Major Depression; Anorexia; Bulimia; OCD; Antidepressant; SSRI; SNRI

Outcome Measures

Primary Outcomes (3)

• Score on the Clinical Global Impression Improvement scale (CGI-I)

  Measured at Months 3, 6, and 9

• Clinician Patient Access to Electronic Records System

  Measured at every visit

• CAPTN Serious Adverse Events (SAE)/Harm-related adverse events form

  Measured at every visit

Secondary Outcomes (4)

• Score on the Clinical Global Impression Severity scale (CGI-S)

  Measured at Months 3, 6, and 9

• Score on the Children's Global Assessment Scale (CGAS)

  Measured at Months 3, 6, and 9

• Parent Coping Strategies Questionnaire (CSQ)

  Measured at every visit

• Youth Coping Strategies Questionnaire (CSQ)

  Measured at every visit

Study Arms (1)

1

Children and adolescents with a pre-specified anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder

Drug: Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications

Interventions

Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medications DRUG

Treatment with SSRIs or SNRIs

1

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents age 7 to 17 years old.

You may qualify if:

• Receiving treatment in an outpatient, residential, or in-patient setting
• Meets DSM-IV diagnostic criteria for at least one of the following disorders: anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
• English- or Spanish-speaking

You may not qualify if:

• Inpatient status IF the enrolling inpatient clinician will not continue to follow the patient for the duration of the study
• Sibling that is already enrolled in the study
• Imminently suicidal and unable to comply with a no-suicide contract or, in the opinion of the treating clinician, has inadequate family monitoring for suicidality
• Acutely psychotic at study entry
• A demonstrated lack of benefit from or intolerance to SSRI/SNRI antidepressants, as a class
• Receiving treatment with a tricyclic antidepressant (TCA) at study enrollment, with the exception of low doses for enuresis for chronic pain. Patients may receive adjunctive TCA treatment during the study at the clinician's discretion.
• Received a monoamine oxidase inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate), within the past 30 days
• Parasuicidal behavior or milder forms of suicidality or activation that do not meet the diagnostic criteria
• Refusal to participate in the pharmacogenomic study
• For bipolar depressed patients, a mixed- or manic-state at study entry without stable treatment with a mood stabilizer for manic symptoms
• Patient or family is unable to comply with the protocol

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Child and Adolescent Psychiatry Trials Network (CAPTN)

Durham, North Carolina, 27715, United States

Location

Related Publications (2)

• March JS, Silva SG, Compton S, Anthony G, DeVeaugh-Geiss J, Califf R, Krishnan R. The Child and Adolescent Psychiatry Trials Network (CAPTN). J Am Acad Child Adolesc Psychiatry. 2004 May;43(5):515-8. doi: 10.1097/00004583-200405000-00004.

  PMID: 15100557 BACKGROUND

• March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R. The case for practical clinical trials in psychiatry. Am J Psychiatry. 2005 May;162(5):836-46. doi: 10.1176/appi.ajp.162.5.836.

  PMID: 15863782 BACKGROUND

Related Links

• Click here for the PARCA trial, a related study by the CAPTN network

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Feeding and Eating Disorders; Obsessive-Compulsive Disorder; Depressive Disorder, Major; Anorexia; Bulimia

Interventions

Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Dosage Forms

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• John S. March, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 2, 2006
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

US (1)