Purpose

The purpose of the study is to assess the tolerability and efficacy of dextromethorphan in combination with fluoxetine for symptom relief in OCD and related disorders.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), illness anxiety disorder (IAD) or somatic symptom disorder (SSD) - Living within California - Capacity to provide informed consent

Exclusion Criteria

  • Current bipolar disorder or psychotic disorder - Active moderate or severe substance use disorder, lifetime severe substance use disorder - Pregnant or nursing women - Use of prescribed psychotropic medications other than fluoxetine for 2 weeks prior to study start - Having commenced OCD-targeted exposure and response-prevention (ExRP) psychotherapy within 2 months of study start

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
After signing consent and baseline assessments, participants will be randomized 1:1 to Group A or Group B for the purposes of sequencing fluoxetine vs combined fluoxetine/dextromethorphan treatment periods.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Symptom rating will be done by independent evaluators blind to treatment allocation.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: fluoxetine then fluoxetine plus dextromethorphan
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.
  • Drug: Fluoxetine
    Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
    Other names:
    • Prozac
  • Drug: Dextromethorphan
    Dextromethorphan, an over-the-counter cough suppressant, will be taken by mouth twice daily for four weeks of the study, starting at 15mg per dose, and increasing weekly as tolerated to a maximum of 60mg per dose.
Experimental
Group B: fluoxetine plus dextromethorphan then fluoxetine
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.
  • Drug: Fluoxetine
    Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
    Other names:
    • Prozac
  • Drug: Dextromethorphan
    Dextromethorphan, an over-the-counter cough suppressant, will be taken by mouth twice daily for four weeks of the study, starting at 15mg per dose, and increasing weekly as tolerated to a maximum of 60mg per dose.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Pavithra Mukunda, MS
650 497 2578
ocdresearch@stanford.edu

Detailed Description

Obsessive compulsive disorder (OCD) and the related disorders body dysmorphic disorder (BDD), somatic symptom disorder (SSD) and illness anxiety disorder (IAD) are psychiatric conditions characterized by recurrent, intrusive thoughts, feelings or images (obsessions or preoccupations) and repetitive or ritualized behaviors or avoidance performed to relieve obsession or preoccupation-related anxiety. They are a significant cause of mental health-related disability, and are inadequately served by available treatments. This study tests whether an over-the-counter cough suppressant medicine, dextromethorphan, may offer symptom relief when combined with a low dose of fluoxetine, a standard prescription treatment for OCD and related disorders.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.