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Recruiting NCT04899687

Study of Dextromethorphan in OCD and Related Disorders

Phase II Interventional Obsessive-Compulsive Disorder Illness Anxiety Disorder Body Dysmorphic Disorders Somatic Symptom Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluoxetine, Dextromethorphan.
Who it may be relevant to
Registry conditions: Obsessive-Compulsive Disorder, Illness Anxiety Disorder, Body Dysmorphic Disorders, Somatic Symptom Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Fluoxetine/Dextromethorphan in Obsessive-Compulsive and Related Disorders: an Open-Label Crossover Pilot Study

Overview

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.

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.

Interventions

  • Drug Fluoxetine
    Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
  • 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.

Primary outcome measures

  • Improvement in OCD or related disorder symptoms as measured by the Y-BOCS [Time frame: Change from baseline will be assessed at 4 weeks and at 8 weeks.]
Secondary outcome measures (1)
  • Improvement in clinical insight as measured by the BABS [Time frame: Change from baseline will be assessed at 4 weeks and at 8 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT04899687 · 60569

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗