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Dextromethorphan + Fluoxetine for Obsessive-Compulsive Disorder

Phase 2
Recruiting
Led By Peter J van Roessel, MD PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), illness anxiety disorder (IAD) or somatic symptom disorder (SSD)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline will be assessed at 4 weeks and at 8 weeks.
Awards & highlights

Study Summary

This trial will study whether a combination of dextromethorphan and fluoxetine is effective and tolerable in treating symptoms of OCD and related disorders.

Who is the study for?
This trial is for California residents with OCD, body dysmorphic disorder, illness anxiety disorder, or somatic symptom disorder who can consent to participate. It excludes those with bipolar or psychotic disorders, pregnant or nursing women, recent users of certain psychotropic drugs other than fluoxetine, and individuals with current severe substance use issues.Check my eligibility
What is being tested?
The study tests the combination of dextromethorphan and fluoxetine for treating symptoms in patients with OCD and related conditions. The goal is to determine how well patients tolerate this combo and its effectiveness in symptom relief.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with fluoxetine such as nausea, sleepiness, sexual dysfunction; dextromethorphan could cause dizziness or mood changes. Specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with OCD, BDD, IAD, or SSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline will be assessed at 4 weeks and at 8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline will be assessed at 4 weeks and at 8 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
Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
Secondary outcome measures
Improvement in clinical insight as measured by the BABS

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635
8%
Stomach Pains
8%
Weight Loss
4%
Silliness/Feeling too happy
4%
Trouble Sleeping
4%
Nightmares
4%
Insomnia
4%
Lit Paper on Fire
4%
Emotional
4%
Menstrual Cramps
4%
Suicidal Behavior
4%
Nausea
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B: fluoxetine plus dextromethorphan then fluoxetineExperimental Treatment2 Interventions
Group B participants will take fluoxetine 20mg (or prior dose) daily together with over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks, and then will stop dextromethorphan, continuing fluoxetine alone for 4 weeks.
Group II: Group A: fluoxetine then fluoxetine plus dextromethorphanExperimental Treatment2 Interventions
Group A participants will take fluoxetine 20mg (or prior dose) daily for 4 weeks, and will then continue fluoxetine while adding over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
2005
Completed Phase 4
~4600
Dextromethorphan
2019
Completed Phase 4
~920

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,303 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,343 Patients Enrolled for Obsessive-Compulsive Disorder
Avy L. & Roberta L. Miller FoundationUNKNOWN
Peter J van Roessel, MD PhDPrincipal InvestigatorStanford University

Media Library

Dextromethorphan (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04899687 — Phase 2
Obsessive-Compulsive Disorder Research Study Groups: Group B: fluoxetine plus dextromethorphan then fluoxetine, Group A: fluoxetine then fluoxetine plus dextromethorphan
Obsessive-Compulsive Disorder Clinical Trial 2023: Dextromethorphan Highlights & Side Effects. Trial Name: NCT04899687 — Phase 2
Dextromethorphan (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899687 — Phase 2

Frequently Asked Questions

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

What adverse effects should be monitored when using Fluoxetine?

"Our internal assessment at Power has concluded that Fluoxetine is relatively safe, scoring a 2 out of 3 due to the fact its safety profile has been demonstrated in Phase 2 trials without any certainty surrounding efficacy."

Answered by AI

Is the enrollment period still open for this investigation?

"As per clinicaltrials.gov, this research is actively recruiting participants. The trial posting was first launched on January 20th 2022 and recently modified on March 15th 2022."

Answered by AI

Does the study include adults over a quarter-century of age?

"Patients aged between 18 and 65 are suitable for this trial. Subsequently, there are 342 trials that accept minors and 884 entries available to those over the age of retirement."

Answered by AI

How many individuals have been recruited to participate in this trial?

"That is correct. According to the data posted on clinicaltrials.gov, this medical study began recruiting patients in January of 2022 and was last updated in March that same year. Overall recruitment goals are set at 60 individuals being enrolled from one location."

Answered by AI

Does my profile meet the criteria to partake in this experiment?

"This clinical trial has a strict eligibility criteria. To be considered, individuals must have body dysmorphic disorder and not exceed the age of 65 nor fall below 18 years old. Additionally, 60 patients are required for this study to proceed."

Answered by AI

What disorders or conditions is Fluoxetine regularly prescribed for?

"Fluoxetine is often prescribed to treat unipolar depression, as well as ocular ailments and sinus-related issues such as rhinorrhoea."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

TO FURTHER UNDERSTAND MY GOALS and BASED ON THE GOALS OF THE STUDY.
PatientReceived no prior treatments
~8 spots leftby Aug 2024