← Back to Search

Selective Serotonin Reuptake Inhibitor

Fluoxetine for Obsessive-Compulsive Disorder

Phase 1 & 2
Recruiting
Led By Christopher Pittenger, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- No documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.
- Treatment seeking, and clinically appropriate for fluoxetine pharmacotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights

Study Summary

This trial will study how well a certain drug works for treating OCD, by looking at brain scans of people before and after taking the drug.

Who is the study for?
This trial is for adults with Obsessive-Compulsive Disorder (OCD) who are seeking treatment and appropriate for fluoxetine therapy. They must not be on psychoactive medication, pregnant, or have a family history of certain disorders. Healthy controls matched by demographics are also included.Check my eligibility
What is being tested?
The study tests the effects of immediate versus delayed treatment with Fluoxetine on brain function in OCD patients using advanced fMRI scans to find predictors and changes associated with the drug's response.See study design
What are the potential side effects?
While side effects aren't detailed here, common ones for Fluoxetine include nausea, headaches, sleep disturbances, anxiety, and sexual dysfunction. The study excludes those with past adverse reactions to SSRIs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My family does not have a history of OCD or related disorders.
Select...
I am considering and suitable for fluoxetine treatment.
Select...
I am not on regular psychoactive medication, except for occasional sleep aids.
Select...
I am an adult willing to participate in a study that aims for diversity in gender, race, and age.
Select...
I have been diagnosed with OCD by a professional.
Select...
I am not pregnant, do not plan to become pregnant, and will use birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Obsessive-compulsive severity change
Secondary outcome measures
"Not Just Right" experiences and sensations in OCD
Anxiety
Beck Depression Inventory-II
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OCD GroupExperimental Treatment2 Interventions
The OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy.
Group II: Healthy ControlsActive Control1 Intervention
The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,843 Previous Clinical Trials
2,735,137 Total Patients Enrolled
10 Trials studying Obsessive-Compulsive Disorder
491 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,673,910 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,881 Patients Enrolled for Obsessive-Compulsive Disorder
Christopher Pittenger, MD, PhDPrincipal InvestigatorProfessor of Psychiatry; Director, Yale OCD Research Clinic
2 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
60 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Fluoxetine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04131829 — Phase 1 & 2
Obsessive-Compulsive Disorder Research Study Groups: Healthy Controls, OCD Group
Obsessive-Compulsive Disorder Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT04131829 — Phase 1 & 2
Fluoxetine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04131829 — Phase 1 & 2
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT04131829 — Phase 1 & 2

Frequently Asked Questions

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

Who has the prerequisites to participate in this clinical experiment?

"This clinical trial is enrolling 120 individuals suffering from Obsessive Compulsive Disorder, aged 18-65. Applicants must satisfy the following criteria: (i) Adults of all genders in a 1:1 ratio with respect to age, handedness and other demographic data; (ii) Signed informed consent approved by Yale's Human Investigations Committee; (iii) Willingness and ability to participate in study procedures including assessments and fMRI scans; (iv) A DSM diagnosis of OCD established via various means; (v) Not currently taking psychoactive medications aside from PRN sleep aids; For women of childbearing potential, not pregnant"

Answered by AI

Are there any historical records of trials with Fluoxetine administered at a later time?

"Currently, 15 studies exploring the efficacy of Fluoxetine - delayed treatment are active with two trials in Phase 3. These tests span 20 different locations across America; however, a majority are located in New Haven, Connecticut."

Answered by AI

What is the total enrollment count for this scientific investigation?

"Affirmative. On clinicaltrials.gov, it is noted that this study opened for enrollment on October 15th 2019 and has been modified as recently as May 31st 2022 - presently recruiting 120 individuals from a single location."

Answered by AI

Are applicants aged 85 or younger admissible to this trial?

"According to the criteria set forth, qualified applicants for this trial must be within 18 and 65 years old. Those younger than 18 or older than 65 have separate clinical trials with 25 and 77 studies respectively."

Answered by AI

Has the FDA greenlighted Fluoxetine - delayed treatment?

"Our team at Power assigned Fluoxetine - delayed treatment a score of 1, due to its Phase 1 trial status indicating limited evidence for both safety and efficacy."

Answered by AI

Are there any available openings for participants in this clinical research?

"According to the clinicaltrials.gov database, this clinical trial is presently accepting new participants. The entry was created on October 15th 2019 and its most recent update occurred on May 31st 2022."

Answered by AI

Does Fluoxetine - delayed treatment often provide aid for what kind of affliction?

"Through Fluoxetine - delayed treatment, medical professionals may be able to provide relief for myoclonus, unipolar depression, and obsessive-compulsive disorder."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Ontario
What site did they apply to?
Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I’ve tried many many other drugs and nothings working.
PatientReceived 1 prior treatment
~7 spots leftby Jul 2024