Body Dysmorphic Disorders, Illness Anxiety Disorder, Obsessive-Compulsive Disorder, Somatic Symptom Disorder
Conditions
Keywords
OCD, BDD, IAD, SSD, Fluoxetine, Dextromethorphan
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.
Interventions
DRUGFluoxetine
Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
DRUGDextromethorphan
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.
Sponsors
Stanford University
Avy L. & Roberta L. Miller Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Symptom rating will be done by independent evaluators blind to treatment allocation.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in OCD or related disorder symptoms as measured by the Y-BOCS | Change from baseline will be assessed at 4 weeks and at 8 weeks. | Improvement in OCD severity is measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a gold standard measure of the severity of obsessions and compulsions. Variants of the Y-BOCS designed for assessment of body dysmorphic disorder or illness anxiety disorder/somatic symptom disorder will be used as appropriate. Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of symptoms. Response will be defined as a 35% reduction in Y-BOCS score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in clinical insight as measured by the BABS | Change from baseline will be assessed at 4 weeks and at 8 weeks. | Improvement in clinical insight is measured by the Brown Assessment of Beliefs Scale (BABS), a scale assessing multiple dimensions of clinical insight as relevant to OCD and related disorders. The BABS rates multiple dimensions of clinical insight related to an identified belief. BABS scores range from 0-24, with higher scores indicating greater insight impairment. Response will be defined as a 35% reduction in BABS score. |
Countries
United States
Contacts
CONTACTAlessa Gaeta, BA
PRINCIPAL_INVESTIGATORPeter J van Roessel, MD PhD
Stanford University
Outcome results
None listed