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Selective Serotonin Reuptake Inhibitor
Fluoxetine for Anxiety and Depression
Phase 2
Recruiting
Led By Daniel S Pine, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ALL SUBJECTS WITH AN ANXIETY DISORDER: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder, Clinically significant ongoing anxiety symptoms, Clinically significant ongoing distress or impairment from anxiety
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly
Awards & highlights
Summary
This trial uses fMRI to study brain regions engaged in processing motivationally salient stimuli in children, adolescents, and adults with mood and anxiety disorders, in order to better understand how these disorders develop and how they can be treated.
Who is the study for?
This trial is for children (8-17 years old) and adults (18-65 years old) with anxiety or major depression, who speak English and have an IQ over 70. It's not for those with serious medical conditions, pregnant women, or individuals currently on SSRIs or with certain psychiatric diagnoses like OCD or mania.
What is being tested?
The study tests how well Fluoxetine, an antidepressant medication, works alongside Attention Bias Modification Training to treat anxiety and depression in kids and adults. Participants will undergo fMRI scans before and after treatment to see if there are changes in brain activity related to mood improvement.
What are the potential side effects?
Fluoxetine can cause nausea, headaches, sleep disturbances, nervousness, sexual dysfunction among other side effects. The severity of these side effects varies from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an anxiety disorder like social phobia or panic disorder that significantly affects my daily life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Improvement (CGI) Scale
Pediatric Anxiety Rating Scale (PARS)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment2 Interventions
Subjects in both treatment arms receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete either the active-intervention arm or the control invention arm. In these arms, either the active or control treatment is administered immediately before a CBT session.
Group II: ControlPlacebo Group1 Intervention
Subjects in both treatment arms receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete either the active-intervention arm or the control invention arm. In these arms, either the active or control treatment is administered immediately before a CBT session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
2005
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)Lead Sponsor
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2,775,006 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own medical decisions.I am between 8 and 17 years old.I can give consent, or if I'm a minor, my parents can and I will agree.My IQ is above 70.I have been diagnosed with an anxiety disorder.I am between 8-17 years old, can understand and agree to participate, have an IQ over 70, and speak English.I am between 18 and 65 years old, can consent, have an IQ over 70, and speak English.I have an anxiety disorder like social phobia or panic disorder that significantly affects my daily life.I have been diagnosed with an anxiety disorder but don't have ongoing significant symptoms.I have been diagnosed with an anxiety disorder.I speak English.My IQ is above 70.I am between 18 and 65 years old.I am an adult.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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