Venlafaxine for Meniere's Disease

Overseen By Habib Rizk, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Medical University of South Carolina

Must not be taking: Venlafaxine, SSRIs, SNRIs, others

Disqualifiers: Seizures, Stroke, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of venlafaxine, an antidepressant, for treating Meniere's disease. Meniere's disease causes dizzy spells and balance problems, and the trial aims to determine if venlafaxine can reduce these symptoms. Participants will receive either venlafaxine or a placebo (a harmless pill with no active medicine) to compare the effects. Individuals who have experienced at least two vertigo episodes in the past month and face moderate dizziness challenges might be suitable for this trial. As a Phase 2/3 trial, the study measures venlafaxine's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial requires that you stop taking venlafaxine, SSRIs, SNRIs, or any other serotonin modulating medications before participating.

Is there any evidence suggesting that venlafaxine is likely to be safe for humans?

Research has shown that venlafaxine is generally safe and well-tolerated. This FDA-approved medication is commonly used for depression and anxiety. While its use for treating Meniere's disease is new, it has a strong safety record for other conditions.

Some individuals might experience side effects such as drowsiness or blurry vision. There is also a rare risk of serotonin syndrome, a serious condition that occurs when there is too much serotonin, a chemical that helps balance mood, in the body.

Overall, many people use venlafaxine without serious issues. However, monitoring for any unusual symptoms and consulting a doctor if they occur is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Meniere's disease?

Unlike the standard treatments for Meniere's disease, which often include diuretics, vestibular suppressants, and lifestyle changes, venlafaxine offers a novel approach by acting as a serotonin and norepinephrine reuptake inhibitor (SNRI). Most treatments for Meniere's focus on managing symptoms like vertigo or fluid retention, but venlafaxine targets the chemical imbalances that might contribute to the condition. This different mechanism of action could potentially address underlying causes, offering a new hope for improved management of symptoms. Researchers are excited about venlafaxine because it opens up a fresh avenue for treating Meniere's disease, possibly leading to more comprehensive symptom relief.

What evidence suggests that venlafaxine might be an effective treatment for Meniere's disease?

Research has shown that venlafaxine, a medication affecting brain chemicals, effectively treats major depression and generalized anxiety disorder (GAD). Studies have found it significantly reduces feelings of anxiety and tension. In this trial, participants will receive either venlafaxine or a placebo to evaluate its potential benefits for Meniere's disease. Although venlafaxine has not been specifically tested for Meniere's disease, its ability to manage anxiety and mood might help with symptoms like vertigo attacks. The medication is known for having fewer side effects related to drowsiness and heart problems, making it safe and well-tolerated. These qualities suggest it could be helpful for people with Meniere's disease, although more specific research is needed. ^{4 6 7 8 9}

Who Is on the Research Team?

Habib Rizk, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

You are currently taking certain types of antidepressants like venlafaxine, SSRIs, or SNRIs.

You have undergone previous medical or surgical treatment that has affected your balance system.

You have other balance or dizziness problems, especially if you experience vertigo due to migraines even if you have not been diagnosed with vestibular migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive venlafaxine or placebo in a randomized, placebo-controlled, double-blind, crossover design

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Venlafaxine

How Is the Trial Designed?

Group I: Venlafaxine Arm Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Venlafaxine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Efexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Approved in United States as Effexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Approved in Canada as Effexor for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

American Hearing Research Foundation

Collaborator

Trials

1

Recruited

40+

American Hearing Research Foundation

Collaborator

Trials

1

Recruited

40+

Cures within Reach Foundation

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor, was found to have a tolerability and safety profile similar to selective serotonin reuptake inhibitors, based on data from 3,082 patients, with most experiencing manageable side effects like nausea and insomnia.

Serious adverse events were rare, and while a small percentage of patients experienced modest increases in blood pressure, these were comparable to those seen with other antidepressants, indicating that venlafaxine is generally safe for both younger and older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database. Rudolph, RL., Derivan, AT.[2022]

Extended-release venlafaxine demonstrated significant efficacy in reducing anxiety symptoms in children and adolescents aged 6 to 17 with generalized anxiety disorder, showing a greater mean decrease in anxiety scores compared to placebo in a pooled analysis of two trials involving 320 participants.

The treatment was generally well-tolerated, although some common side effects were reported, including fatigue and changes in weight and vital signs, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended-release venlafaxine in the treatment of generalized anxiety disorder in children and adolescents: two placebo-controlled trials. Rynn, MA., Riddle, MA., Yeung, PP., et al.[2022]

Venlafaxine is safe and well tolerated in patients with major depression, based on data from 19 studies involving 2181 patients, with a long-term safety evaluation in 422 patients treated for at least one year.

The adverse events associated with venlafaxine, such as nausea and headache, were common but comparable to those seen with third-generation antidepressants, and venlafaxine had a lower frequency of anticholinergic events compared to first-generation antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerance profile of venlafaxine. Danjou, P., Hackett, D.[2019]

Venlafaxine is more effective than selective serotonin reuptake inhibitors (SSRIs) in treating major depression, with a greater likelihood of achieving a therapeutic response and remission, as shown by a meta-analysis of various trials.

In patients with treatment-resistant depression, venlafaxine demonstrated superior efficacy compared to alternative antidepressants, and it also significantly reduced the risk of relapse when used long-term after a major depressive episode.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of venlafaxine compared with other antidepressants and placebo in the treatment of major depression: a meta-analysis. Bauer, M., Tharmanathan, P., Volz, HP., et al.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK78127/

The effect of venlafaxine compared with other antidepressants ... The authors concluded that venlafaxine was clinically effective in achieving therapeutic response and remission in patients with major depression.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK535363/

Venlafaxine - StatPearls - NCBI Bookshelf Venlafaxine causes a lower frequency of anticholinergic, sedating, and cardiovascular adverse effects but a higher incidence of gastrointestinal complaints, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00183274

Study Details | NCT00183274 | Effectiveness of Long-Term ... This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment ...

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.157.6.968

Efficacy of Extended-Release Venlafaxine in ... Finally, venlafaxine XR treatment led to significant improvement in items 1 and 2 (anxious mood and tension, respectively) on the Hamilton anxiety scale, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022395620308438

Clustering patients by depression symptoms to predict ... Three unique clusters of patients were identified differing in baseline mCore symptoms and anxiety. Cluster membership may predict efficacy outcomes.

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/PZ01391.pdf

MATERIAL SAFETY DATA SHEET Additional Hazard Information: Short Term: Individuals taking monoamine oxidase (MAO) inhibitors should avoid exposure to this material. Long Term:.

7. mayoclinic.org mayoclinic.org/drugs-supplements/venlafaxine-oral-route/description/drg-20067379

Venlafaxine (oral route) - Side effects & dosage Venlafaxine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, ...

8. effexorxr.com effexorxr.com/

EFFEXOR XR® (venlafaxine HCl) Homepage | Safety Info Taking EFFEXOR XR can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/020699s107lbl.pdf

EFFEXOR XR® (venlafaxine Extended-Release) Capsules The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Coadministration of ...