Anxiety DisordersPhase 3NCT00000381
Fluoxetine for Anxious Children
A Phase 3 study testing Fluoxetine in people with Anxiety Disorders, run by University of Pittsburgh.
Trial summary
The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD). Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Fluoxetine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1997to May 2003
- Phase
- Phase 3
- 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 8 to 17 years
- All sexes
- Child
Who may be able to join
- -
- Patients must have:
- Generalized anxiety disorder.
Who cannot join
- -
- Excluded:
- Patients with current major depression, as well as patients with panic and obsessive-compulsive disorder.
- -
- Excluded:
- Current substance abuse.
About this study
The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD).
Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children.
Read more
Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks.
A child is eligible for this study if he/she:
Is 8 to 17 years old and has anxiety disorder.
A child will not be eligible for this study if he/she:
Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.
Read the detailed description
To evaluate the safety and efficacy of fluoxetine as a treatment for children and adolescents with Generalized Anxiety Disorder (GAD).
Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic, social, and family morbidity. These disorders frequently increase the risk for developing other psychiatric disorders (e.g., depression, substance abuse), aggregate in families, and appear to continue into adulthood. Except for Obsessive-Compulsive Disorder, there are very few pharmacological treatment studies for childhood anxiety disorders. Given the sparsity and methodological problems of previous anxiety pharmacological studies, it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed.
Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks. Patients are assessed for psychiatric symptomatology, functional status, and side effects. In addition, to assess attainment of steady state and compliance with treatment, plasma levels of fluoxetine and norfluoxetine are measured at 4, 8, and 12 weeks. To standardize the treatment protocol and to assure that both groups (fluoxetine and placebo) receive equivalent nonpharmacological treatment, a manual is used. Potential predictors of clinical response (such as age, sex, duration and severity of anxiety, school absenteeism, sub-syndromal depressive symptoms, family history of anxiety or mood disorders) are explored.
- Conditions
- Anxiety Disorders
- Being tested
- Fluoxetine
- Keywords
- Adolescence, Anxiety Disorders, Child, Female, Fluoxetine, Male, Placebos, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluoxetine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startJun 1997
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Boris Birmaher, MD, University of Pittsburgh
- Investigators
- Boris Birmaher, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000381
- Sponsor's protocol ID
- R01MH053681
- Other IDs
- R01MH053681, DSIR
- Status last verified
- Dec 2005
- First submitted
- 2 Nov 1999
- Last updated
- 8 Jan 2014
- Results posted
- No
Publications
Birmaher B, Axelson DA, Monk K, Kalas C, Clark DB, Ehmann M, Bridge J, Heo J, Brent DA. Fluoxetine for the treatment of childhood anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):415-23. doi: 10.1097/01.CHI.0000037049.04952.9F.
PubMed 12649628
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
- Fluoxetine for Anxious Children
- ClinicalTrials.gov ID
- NCT00000381
- Acronym / sponsor ID
- R01MH053681
- Conditions
- Anxiety Disorders
- Keywords
- Adolescence, Anxiety Disorders, Child, Female, Fluoxetine, Male, Placebos, Serotonin Uptake Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 1997
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 3 Nov 1999 (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.
The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD).
Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children.
Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks.
A child is eligible for this study if he/she:
Is 8 to 17 years old and has anxiety disorder.
A child will not be eligible for this study if he/she:
Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.
Detailed description
To evaluate the safety and efficacy of fluoxetine as a treatment for children and adolescents with Generalized Anxiety Disorder (GAD).
Anxiety disorders are among the most common childhood and adolescent psychiatric disorders and are often associated with academic, social, and family morbidity. These disorders frequently increase the risk for developing other psychiatric disorders (e.g., depression, substance abuse), aggregate in families, and appear to continue into adulthood. Except for Obsessive-Compulsive Disorder, there are very few pharmacological treatment studies for childhood anxiety disorders. Given the sparsity and methodological problems of previous anxiety pharmacological studies, it is clear that further investigation of the use of pharmacological treatment of children and adolescents with these disorders is needed.
Patients are randomized to receive either fixed-dose fluoxetine or placebo for 12 weeks. Patients are assessed for psychiatric symptomatology, functional status, and side effects. In addition, to assess attainment of steady state and compliance with treatment, plasma levels of fluoxetine and norfluoxetine are measured at 4, 8, and 12 weeks. To standardize the treatment protocol and to assure that both groups (fluoxetine and placebo) receive equivalent nonpharmacological treatment, a manual is used. Potential predictors of clinical response (such as age, sex, duration and severity of anxiety, school absenteeism, sub-syndromal depressive symptoms, family history of anxiety or mood disorders) are explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- -
- Generalized anxiety disorder.
Key exclusion criteria (6 listed)
- -
- Patients with current major depression, as well as patients with panic and obsessive-compulsive disorder.
- -
- Current substance abuse.
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
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 8 Jan 2014.
- Results publication: PubMed 12649628Birmaher B, Axelson DA, Monk K, Kalas C, Clark DB, Ehmann M, Bridge J, Heo J, Brent DA. Fluoxetine for the treatment of childhood anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):415-23. doi: 10.1097/01.CHI.0000037049.04952.9F.
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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.
Boris Birmaher, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine in people with Anxiety Disorders, run by University of Pittsburgh.
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 3 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00000381, which also lists 1 linked publication.
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.