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New treatment option for Anxiety Disorders
Official title Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
ClinicalTrials.gov ID: NCT00018057
What this study is testing
What is Fluoxetine?
Fluoxetine is an investigational medicine, being studied as a potential treatment for anxiety disorders.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 65. Healthy volunteers may be eligible.
You may be able to join if
- ALL JUVENILE people
- Age: 8-17 (people who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by...
- Consent: can give consent/assent (Parents will provide consent; minors will provide assent)
- IQ: all people will have IQ\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit...
- Language: all people will speak English (Tasks in this protocol have not been validated in languages other than English) ALL ADULT people
You likely can't join if
- ALL people
- Any serious medical condition or condition that interferes with fMRI or M/EEG scanning, and for patients electing medication, any condition that...
- Pregnancy (people only will be excluded from the MRI portions of the study based on this exclusion criterion.)
- Current use of any psychoactive substance; current suicidal ideation as indicated by the presence of intent for engaging in suicidal behaviors...
- Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI...
- Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment...
See the full eligibility criteria
- ALL JUVENILE people
- Age: 8-17 (people who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other people who consent as 17-year-olds but do not turn 18).
- Consent: can give consent/assent (Parents will provide consent; minors will provide assent)
- IQ: all people will have IQ\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an...
- Language: all people will speak English (Tasks in this protocol have not been validated in languages other than English) ALL ADULT people
- Age: 18-65
- Consent: can give consent
- IQ: all people will have IQ\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an...
- Language: all people will speak English (Tasks in this protocol have not been validated in languages other than English) ALL people WITH AN ANXIETY DISORDER
- Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))
- Symptom Severity: Clinically significant, ongoing anxiety symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)
- Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety (This will be documented by clinician review with patients and their families during at least two visits with families.) ALL...
- Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults))
- Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)
- Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)
- ALL people
- Any serious medical condition or condition that interferes with fMRI or M/EEG scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. (All patients will complete a medical...
- Pregnancy (people only will be excluded from the MRI portions of the study based on this exclusion criterion.)
- Current use of any psychoactive substance; current suicidal ideation as indicated by the presence of intent for engaging in suicidal behaviors; current diagnosis of attention deficit hyperactivity disorder (ADHD) of...
- Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of...
- Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of depression. Of...
- Recent use of an SSRI with failure to respond or tolerate SSRI treatment at an adequate dose and duration. (This is designed to exclude people who have failed a trial of an SSRI for their current problem with anxiety...
- History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence). HEALTHY ADULT people -Any current psychiatric diagnosis...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- College Park, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; College Park, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.