The Treatment of Children and Adolescents With Treatment-Resistant Depression

NCT00029640 | Completed

• 2 other identifiers: 02010802-M-0108
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

MRI; MRS; SSRI; Children; Depression; Augmentation; Magnetic Resonance Imaging; Major Depression; MDD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. doi: 10.1097/00004583-199611000-00011.

  PMID: 8936909 BACKGROUND

• Emslie GJ, Rush AJ, Weinberg WA, Kowatch RA, Hughes CW, Carmody T, Rintelmann J. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997 Nov;54(11):1031-7. doi: 10.1001/archpsyc.1997.01830230069010.

  PMID: 9366660 BACKGROUND

• Hamilton JD, Bridge J. Outcome at 6 months for 50 adolescents with major depression treated in a health maintenance organization. J Am Acad Child Adolesc Psychiatry. 1999 Nov;38(11):1340-6. doi: 10.1097/00004583-199911000-00007.

  PMID: 10560219 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 16, 2002
• First Posted: January 17, 2002
• Study Start: January 1, 2002
• Study Completion: March 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-03

Locations

US (1)