Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

Overview

About this study

Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.

The primary goal of this study to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Fifty patients diagnosed with coexisting VM-CSD will be treated with either verapamil or sertraline. Based on clinical and research experience to date, verapamil is thought to have greater effect on migraine-related symptoms, whereas sertraline is thought to have greater effect on CSD-related symptoms. It is hypothesized that a differential treatment response to these two pharmacologic probes will help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. The different mechanisms of action of the two study medications may also shed light on the physiologic underpinnings of VM and CSD.

This project will be a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection trial. A 12-week treatment period will follow 2 weeks of baseline observation. Patients will chart daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression will be measured at two week intervals. Data will be analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion criteria

Neurotologic diagnoses of both vestibular migraine and chronic subjective dizziness
All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
Able to complete study assessments in person and by phone
Able to travel to Mayo Clinic, Rochester, MN for first and last study visits
Willing to avoid pregnancy during study (abstinence or acceptable birth control)

Exclusion criteria

Presence of any other active neurotologic diagnoses
Medical or psychiatric conditions that would preclude or confound study drugs
Use of medications or supplements that would preclude or confound study drugs
Past treatment of headache or dizziness with a full trial of a calcium channel blocker or selective serotonin reuptake inhibitor
Allergy to verapamil or sertraline

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Jeffrey Staab, M.D.	Closed for enrollment
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Jeffrey Staab, M.D.	Closed for enrollment	Contact information: Todd Schwedt M.D. (480)301-8000 Schwedt.Todd@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Staab, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeffrey Staab, M.D.

Closed for enrollment

Contact information:

Todd Schwedt M.D.

(480)301-8000

Schwedt.Todd@mayo.edu

More information

Publications

To investigate the following: 1) associations between vestibular symptoms and migraine in a well-characterized cohort of tertiary neurotology patients, 2) effects of comorbidity on clinical presentations, and 3) validity of proposed definitions of definite (dVM) and probable vestibular migraine (pVM). Read More on PubMed
This article reviews the authors' work, which expands on previous studies to confirm that anxiety-related processes cause or maintain symptoms of dizziness. Discussed are interventions directed at patients' underlying psychologic disorders, including current methods of pharmacotherapy and psychotherapy. Patients with chronic complaints of nonspecific dizziness can present frustrating diagnostic and therapeutic challenges, but can be offered definitive and palliative care. The authors emphasize the importance of eliciting a precise description of the dizziness sensation from the patient as the critical factor in delineating the specific diagnosis and guiding treatment. Read More on PubMed
To improve treatment outcomes for patients with chronic dizziness by identifying clinical conditions associated with persistent symptoms and delineating key diagnostic features that differentiate its causes and direct attention to specific treatments. Read More on PubMed

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