Health TrialsbyHealthPanel

Study of Dextromethorphan in OCD and Related Disorders

ConditionsObsessive-Compulsive DisorderIllness Anxiety DisorderBody Dysmorphic DisordersSomatic Symptom Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fluoxetine

    Drug

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

  • Dextromethorphan

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A: fluoxetine then fluoxetine plus dextromethorphanExperimental treatment 2 interventions
Group B: Group B: fluoxetine plus dextromethorphan then fluoxetineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline will be assessed at 4 weeks and at 8 weeks.

Secondary outcomes

1

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.

Time frame
Change from baseline will be assessed at 4 weeks and at 8 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Avy L. & Roberta L. Miller Foundation

Collaborator

Source ClinicalTrials.gov
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