Clinical trial NCT04899687: Study of Dextromethorphan in OCD and Related Disorders
Official title: Fluoxetine/Dextromethorphan in Obsessive-Compulsive and Related Disorders: an Open-Label Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Illness Anxiety Disorder
Body Dysmorphic Disorders
Somatic Symptom Disorder
Keywords: OCD
BDD
IAD
SSD
Fluoxetine
Dextromethorphan
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Avy L. & Roberta L. Miller Foundation
First posted: 2021-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.

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

Primary outcomes:
measure: Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
timeFrame: Change from baseline will be assessed at 4 weeks and at 8 weeks.
Secondary outcomes:
measure: Improvement in clinical insight as measured by the BABS
timeFrame: Change from baseline will be assessed at 4 weeks and at 8 weeks.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Peter J van Roessel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: