Bipolar DisorderNCT00029640
The Treatment of Children and Adolescents With Treatment-Resistant Depression
An observational study of Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Clinical and Neurochemical Effects of Pharmacologic Treatment in Pediatric Depression
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Keywords
- MRI, MRS, SSRI, Children, Depression, Augmentation, Magnetic Resonance Imaging, Major Depression, MDD
- Medical subject headings
- Bipolar Disorder, Depression, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2002 (estimated)
- Study startJan 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029640
- Sponsor's protocol ID
- 020108
- Other IDs
- 02-M-0108
- Status last verified
- Mar 2004
- First submitted
- 16 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8936909Emslie 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.
PubMed 9366660Hamilton 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.
PubMed 10560219
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurochemical Effects of Pharmacologic Treatment in Pediatric Depression
- ClinicalTrials.gov ID
- NCT00029640
- Acronym / sponsor ID
- 020108
- Conditions
- Bipolar Disorder
- Keywords
- MRI, MRS, SSRI, Children, Depression, Augmentation, Magnetic Resonance Imaging, Major Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Mar 2004
- First posted
- 17 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8936909Birmaher 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.
- Background: PubMed 9366660Emslie 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.
- Background: PubMed 10560219Hamilton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029640, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.