The Treatment of Children and Adolescents With Treatment-Resistant Depression

Completed

Conditions studied: Bipolar Disorder

In brief

This study seeks to learn about brain function in adolescents with depression and to determine whether adding lithium carbonate to antidepressant medication can reduce depression in children and adolescents. Functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) will examine brain chemistry and function.

Key facts

Study ID

NCT00029640

Run by

National Institute of Mental Health (NIMH)

People needed

90

Starts

2002-01-01

Expected to finish

2004-03-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects
• Age: 9 to 17.
• Consent: can give consent/assent.
• IQ: All subjects will have IQ greater than 70.
• Severity Criterion: CDRS greater than 39.
• Impairment: All subjects will have a CGAS less than 60.
• SUBJECTS WITH A RESISTANT MDD:
• Diagnosis: Current Diagnosis of Major Depression.
• Treatment Resistant:At least six-weeks continual use of an SSRI, the last two of which are at high dose by the research team; CGI-S greater than 2 confirmed by observation during an additional two weeks (at least 8-weeks total duration).
• MEDICATION-FREE MDD SUBJECTS:
• Diagnosis: Current Diagnosis of Major Depression
• Clinical Impairment: CGAS less than 60.
• Medication-Free: No psychotropic medications for two month period; depressed for less than 6 months.

You may not qualify if…

• Any medical condition that increases risk for SSRI or lithium treatment or for MRI exam. This will include screening for standard MRI scanning contraindications such as metallic implants or pacemakers.
• Pregnancy.
• Current use of any psychoactive substance beyond ab SSRI; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy.
• Current diagnoses: Tourette's Disorder, OCD, post-traumatic stress disorder, conduct disorder.
• Past or current history of mania, psychosis, or pervasive developmental disorder.
• Long-Term SSRI Treatment: Subjects who have been receiving an SSRI medication for 12 wks or longer upon entry into the observational phase of the study will not be eligible for participation.

Where it is running

• National Institute of Mental Health (NIMH) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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