Back to resultsStudy of Dextromethorphan in OCD and Related Disorders
Primary Purpose
Obsessive-Compulsive Disorder, Illness Anxiety Disorder, Body Dysmorphic Disorders
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Dextromethorphan
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, BDD, IAD, SSD, Fluoxetine, Dextromethorphan
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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A: fluoxetine then fluoxetine plus dextromethorphan
Group B: fluoxetine plus dextromethorphan then fluoxetine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
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 Outcome Measures
Improvement in clinical insight as measured by the BABS
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.
Full Information
NCT ID
NCT04899687
First Posted
May 13, 2021
Last Updated
April 11, 2023
Sponsor
Stanford University
Collaborators
Avy L. & Roberta L. Miller Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04899687
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Avy L. & Roberta L. Miller Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Illness Anxiety Disorder, Body Dysmorphic Disorders, Somatic Symptom Disorder
Keywords
OCD, BDD, IAD, SSD, Fluoxetine, Dextromethorphan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Masking Description
Symptom rating will be done by independent evaluators blind to treatment allocation.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: fluoxetine then fluoxetine plus dextromethorphan
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: fluoxetine plus dextromethorphan then fluoxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
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 Measure Information:
Title
Improvement in OCD or related disorder symptoms as measured by the Y-BOCS
Description
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.
Time Frame
Change from baseline will be assessed at 4 weeks and at 8 weeks.
Secondary Outcome Measure Information:
Title
Improvement in clinical insight as measured by the BABS
Description
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.
Time Frame
Change from baseline will be assessed at 4 weeks and at 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavithra Mukunda, MS
Phone
650 497 2578
Email
ocdresearch@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J van Roessel, MD PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavithra Makunda, MS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Sindu Menon, MBBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Peter van Roessel, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Dextromethorphan in OCD and Related Disorders
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