DepressionNCT00332787
Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
A study testing Fluoxetine in people with Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Fluoxetine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Oct 2005
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Currently being treated on an outpatient basis
- Currently attending school
- Diagnosis of non-psychotic major depressive disorder (MDD)
- Duration of illness is at least 4 weeks
- In good general medical health
- Normal intelligence
Who cannot join
- Lifetime history of any psychotic disorder, including psychotic depression
- Diagnosis of bipolar I or II disorder
- History of alcohol or substance abuse or dependence within 6 months of study entry
- Lifetime history of anorexia nervosa or bulimia
- Pregnant or breastfeeding
- Does not agree to use an effective form of contraception (i.e., IUD, birth control pills, or barrier devices)
Show all 10Show fewer
- Any chronic medical illness requiring regular medication
- Currently taking medication with psychotropic effects (i.e., anticonvulsants, steroids, etc.), other than stable stimulant treatment
- A first degree relative has bipolar I disorder
- Previous adequate treatment with fluoxetine was ineffective (defined as at least 20 mg/day for 4 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center at Dallas, Outpatient Psychiatry Clinic
Dallas, Texas, 75235
About this study
Official title: Childhood Depression: Remission and Relapse
This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.
Read the detailed description
Depression is a serious medical illness that affects all ages and populations. However, it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents. Symptoms of depression in this age group vary, but some common signs include pretending to be sick, refusing to go to school, clinging to a parent, or worrying that a parent may die. Older children may sulk, get into trouble at school, act in a negative or grouchy way, or feel misunderstood. Recent studies on selective serotonin reuptake inhibitors (SSRIs), one class of antidepressant medications, have shown that SSRIs are effective in reducing depression symptoms. The optimal duration of treatment, however, has yet to be established. This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.
Participants in this study will first attend three study visits over a 2-week period to determine eligibility. All eligible individuals will be treated with fluoxetine for 12 weeks. Dosages will be determined by the study physician and will be based on clinical response to treatment. Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months. Depression symptoms, general changes, and adverse reactions will be assessed. Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study, which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks. Study visits will occur biweekly for 3 months and monthly for the remaining 3 months. Depression symptoms and medication side effects will be assessed at these visits.
- Conditions
- Depression
- Being tested
- Fluoxetine
- Keywords
- Major Depressive Disorder
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured throughout the study: Relapse
Time to relapse
Secondary outcomes (2)
Measured at Weeks 12 and 36: Functioning
Baseline characteristics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startJun 2000
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Graham J. Emslie, MD, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332787
- Sponsor's protocol ID
- R01MH039188
- Other IDs
- R01MH039188, DSIR CT-M
- Status last verified
- Jan 2014
- First submitted
- 1 Jun 2006
- Last updated
- 8 Jan 2014
- Results posted
- No
Publications
Kennard BD, Mayes TL, Chahal Z, Nakonezny PA, Moorehead A, Emslie GJ. Predictors and Moderators of Relapse in Children and Adolescents With Major Depressive Disorder. J Clin Psychiatry. 2018 Mar/Apr;79(2):15m10330. doi: 10.4088/JCP.15m10330.
PubMed 29474007Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
PubMed 20973714Tao R, Emslie G, Mayes T, Nakonezny P, Kennard B, Hughes C. Early prediction of acute antidepressant treatment response and remission in pediatric major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):71-8. doi: 10.1097/CHI.0b013e318190043e.
PubMed 19057412Kennard BD, Hughes JL, Stewart SM, Mayes T, Nightingale-Teresi J, Tao R, Carmody T, Emslie GJ. Maternal depressive symptoms in pediatric major depressive disorder: relationship to acute treatment outcome. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):694-699. doi: 10.1097/CHI.0b013e31816bfff5.
PubMed 18434919
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Depression: Remission and Relapse
- ClinicalTrials.gov ID
- NCT00332787
- Acronym / sponsor ID
- R01MH039188
- Conditions
- Depression
- Keywords
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2000
- Study completion
- Oct 2005
- First posted
- 2 Jun 2006 (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 will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.
Detailed description
Depression is a serious medical illness that affects all ages and populations. However, it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents. Symptoms of depression in this age group vary, but some common signs include pretending to be sick, refusing to go to school, clinging to a parent, or worrying that a parent may die. Older children may sulk, get into trouble at school, act in a negative or grouchy way, or feel misunderstood. Recent studies on selective serotonin reuptake inhibitors (SSRIs), one class of antidepressant medications, have shown that SSRIs are effective in reducing depression symptoms. The optimal duration of treatment, however, has yet to be established. This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.
Participants in this study will first attend three study visits over a 2-week period to determine eligibility. All eligible individuals will be treated with fluoxetine for 12 weeks. Dosages will be determined by the study physician and will be based on clinical response to treatment. Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months. Depression symptoms, general changes, and adverse reactions will be assessed. Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study, which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks. Study visits will occur biweekly for 3 months and monthly for the remaining 3 months. Depression symptoms and medication side effects will be assessed at these visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Currently being treated on an outpatient basis
- Currently attending school
- Diagnosis of non-psychotic major depressive disorder (MDD)
- Duration of illness is at least 4 weeks
- In good general medical health
Key exclusion criteria (10 listed)
- Lifetime history of any psychotic disorder, including psychotic depression
- Diagnosis of bipolar I or II disorder
- History of alcohol or substance abuse or dependence within 6 months of study entry
- Lifetime history of anorexia nervosa or bulimia
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine | Drug | – |
Primary outcome
Measured throughout the study: Relapse
Time to relapse
2 secondary outcomes
Measured at Weeks 12 and 36: Functioning
Baseline characteristics
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 8 Jan 2014.
- Derived from this study: PubMed 29474007Kennard BD, Mayes TL, Chahal Z, Nakonezny PA, Moorehead A, Emslie GJ. Predictors and Moderators of Relapse in Children and Adolescents With Major Depressive Disorder. J Clin Psychiatry. 2018 Mar/Apr;79(2):15m10330. doi: 10.4088/JCP.15m10330.
- Derived from this study: PubMed 20973714Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
- Derived from this study: PubMed 19057412Tao R, Emslie G, Mayes T, Nakonezny P, Kennard B, Hughes C. Early prediction of acute antidepressant treatment response and remission in pediatric major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):71-8. doi: 10.1097/CHI.0b013e318190043e.
- Derived from this study: PubMed 18434919Kennard BD, Hughes JL, Stewart SM, Mayes T, Nightingale-Teresi J, Tao R, Carmody T, Emslie GJ. Maternal depressive symptoms in pediatric major depressive disorder: relationship to acute treatment outcome. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):694-699. doi: 10.1097/CHI.0b013e31816bfff5.
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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.
Graham J. Emslie, MD principal investigator
UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Depression, run by University of Texas Southwestern Medical Center 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 6 inclusion and 10 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 8 Jan 2014. 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.
What does the primary outcome measure?
Measured throughout the study: Relapse. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00332787, which also lists 4 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 8 Jan 2014.