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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor

2,786 Previous Clinical Trials

2,687,169 Total Patients Enrolled

157 Trials studying Anxiety Disorders

62,858 Patients Enrolled for Anxiety Disorders

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,586,245 Total Patients Enrolled

11 Trials studying Anxiety Disorders

2,456 Patients Enrolled for Anxiety Disorders

University of OregonOTHER

80 Previous Clinical Trials

44,376 Total Patients Enrolled

Media Library

Fluoxetine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00018057 — Phase 2

Anxiety Disorders Research Study Groups: Active, Control

Anxiety Disorders Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT00018057 — Phase 2

Fluoxetine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00018057 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant selection criterion of this trial inclusive of individuals over four decades old?

"Participants aged 8 and up to 65 are being accepted for this clinical trial."

Answered by AI

What safety measures are in place when utilizing Attention Bias Modification Training?

"ABMT's safety has been partially corroborated by Phase 2 clinical trials, thus resulting in a score of two. While there is evidence that it does not present major risks to users, no studies have determined its efficacy yet."

Answered by AI

Are there previous experiments that have employed Attention Bias Modification Training?

"Presently, 15 distinct trials are underway researching Attention Bias Modification Training. 2 of these studies have advanced to Phase 3 and a further 20 sites across the country are running similar investigations. These clinical centres mainly reside in New Haven, Connecticut."

Answered by AI

Are there still openings for volunteers to participate in this research?

"Affirmative. According to information hosted on clinicaltrials.gov, this research is still recruiting participants since it was first posted on October 2nd 2001 and last modified November 8th 2022. The trial requires 2530 patients between two different sites to take part in the study."

Answered by AI

How many participants are currently involved in this trial?

"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical experiment, which was originally posted on October 2nd 2001, is actively recruiting participants. The researchers aim to find 2530 patients between two different sites for the trial."

Answered by AI

What psychological issues can Attention Bias Modification Training help remediate?

"Attention Bias Modification Training is an efficient treatment for myoclonus, and may likewise aid those suffering from unipolar depression, obsessive-compulsive disorder, or anorexia nervosa."

Answered by AI

Is it feasible to partake in this experiment?

"This clinical trial is recruiting up to 2530 individuals, aged 8-65 who suffer from an anxiety disorder. The criteria for eligibility are as follows: Age range of 8-17 years old (with parental consent and minor assent) or 18-65 years old with capacity to give informed consent; Minimum IQ of 70 assessed through WASI; English speaking only; Diagnosis of Social Phobia, Separation Anxiety Disorder, Generalized Anxiety Disorder or Panic Disorder based on KSADS (for minors) or SCID (adults)."

Answered by AI