What side effects are associated with this type of intervention?

Selective Serotonin Reuptake Inhibitors (SSRIs) such as fluoxetine are commonly used to treat OCD and can cause side effects including nausea, headache, insomnia, sexual dysfunction, and increased anxiety. NMDA receptor antagonists, like dextromethorphan, may cause dizziness, fatigue, confusion, and gastrointestinal disturbances. Combining these treatments may increase the risk of serotonin syndrome, characterized by symptoms such as agitation, hallucinations, rapid heart rate, and changes in blood pressure.

What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD), including fluoxetine, fluvoxamine, sertraline, and paroxetine. These medications are commonly used due to their efficacy in reducing OCD symptoms. Additionally, clomipramine, a tricyclic antidepressant with strong serotonergic properties, is also FDA-approved for OCD. While NMDA receptor antagonists like dextromethorphan are being studied for their potential benefits in combination with SSRIs, they have not yet received FDA approval specifically for OCD treatment.

What other types of research exist?

Promising novel alternatives for OCD treatment include Deep Brain Stimulation (DBS), which has shown promising results in preliminary trials for treatment-refractory OCD, and cognitive-behavioral therapy (CBT) combined with DBS, which appears particularly effective. Additionally, serotonergic antidepressants and transcranial magnetic stimulation (TMS) are alternative interventions being explored for severe OCD.

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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

Must not have

Current bipolar disorder or psychotic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline will be assessed at 4 weeks and at 8 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a common cough medicine can help when taken with a low dose of a usual obsessive-compulsive disorder (OCD) medication. It targets patients with OCD and related disorders who often do not get enough help from current treatments. The cough medicine might work with the usual drug to better control troubling thoughts and actions. The usual medication is a well-established treatment for obsessive-compulsive disorder and has been shown to be effective in multiple studies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have bipolar or psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline will be assessed at 4 weeks and at 8 weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in OCD or related disorder symptoms as measured by the Y-BOCS

Secondary study objectives

Improvement in clinical insight as measured by the BABS

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Weight Loss

Stomach Pains

Trouble Sleeping

Nausea

Menstrual Cramps

Insomnia

Nightmares

Silliness/Feeling too happy

Emotional

Suicidal Behavior

Lit Paper on Fire

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fluoxetine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2370

Dextromethorphan

2019

Completed Phase 4

~920

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine increase serotonin levels in the brain by inhibiting its reuptake, which helps improve mood and reduce anxiety, key factors in managing OCD symptoms. NMDA receptor antagonists, such as dextromethorphan, modulate glutamate activity, influencing neuroplasticity and reducing compulsive behaviors. These mechanisms are important for OCD patients as they target specific neurotransmitter systems involved in the disorder, aiding in better symptom management and enhancing quality of life.