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The Treatment of Children and Adolescents With Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00029640
Recruitment Status : Completed
First Posted : January 17, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date January 16, 2002
First Posted Date January 17, 2002
Last Update Posted Date March 4, 2008
Study Start Date January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Treatment of Children and Adolescents With Treatment-Resistant Depression
Official Title Clinical and Neurochemical Effects of Pharmacologic Treatment in Pediatric Depression
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.
Detailed Description

The participants may or may not have taken a selective serotonin reuptake inhibitor (SSRI) (such as paroxetine (Paxil), sertraline (Zoloft) or fluoxetine (Prozac)) to treat their depression.

The participants and their parents are interviewed both individually and together with questions about the child's general mood, degree of nervousness, and behavior and how family members are doing. Children and adolescents will have a physical examination, blood tests, and intelligence and memory evaluations. Tests include standardized questions and tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices. Participants spend time in a, mock MRI scanner, to become comfortable with the procedure. Participants and their parents meet weekly for 2 weeks with a psychologist or psychiatrist for sessions. Those who remain depressed after these two sessions will begin study medication.

Those who are not currently taking an SSRI will be offered paroxetine. Those already taking an SSRI will be randomly assigned to receive either lithium or a placebo (non-active pill) in addition to the SSRI. Treatment continues for 8 weeks. During this time, the participant and parent meet with the doctor once a week and complete written and oral evaluations. Blood will be drawn before medication begins and at the end of the 8-week treatment. Participants will have additional blood taken after 1 week on medication to help in deciding whether dose adjustment is needed. Additional blood tests might be needed later on to ensure that the dose is correct. Those who improve after 8 weeks will continue treatment at NIH until responsibility for their care can be assume by an outside physician. Program staff will help in facilitating referrals to physicians who will monitor the medication after the child leaves the study.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
90
Original Enrollment Same as current
Study Completion Date March 2004
Primary Completion Date Not Provided
Eligibility Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00029640
Other Study ID Numbers 020108
02-M-0108
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2004