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

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for reporting.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluoxetine

2005

Completed Phase 4

~2370

0 / 1Eligibility criteria met