Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes

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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests venlafaxine, a medication for depression and anxiety, on patients with Meniere's disease. The goal is to see if it can help reduce vertigo and other symptoms by balancing brain chemicals. Venlafaxine is the first member of a new class of antidepressants that affects both serotonin and norepinephrine.

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 venlafaxine safe for humans?

Venlafaxine has been shown to be generally safe and well-tolerated in humans, with common side effects including nausea, headache, and dizziness. Serious adverse events are rare, and its safety profile is similar to other modern antidepressants. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Venlafaxine?

Research shows that Venlafaxine is effective in treating major depression, with significant improvements in depression scores compared to a placebo. It is particularly effective for severe depression and is well-tolerated, with common side effects being nervousness, sweating, and nausea. ^{6 7 8 9 10}

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 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]

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 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]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of venlafaxine extended release and conventional antidepressants in elderly patients with depressive disorder]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment with venlafaxine extended release after SSRI nonresponse or intolerance: a randomized comparison of standard- and higher-dosing strategies. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of venlafaxine in the treatment of severe depression. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The effect of venlafaxine compared with other antidepressants and placebo in the treatment of major depression: a meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo-controlled trial of venlafaxine for the treatment of major depression. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Safety and tolerance profile of venlafaxine. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Therapeutic drug monitoring of racemic venlafaxine and its main metabolites in an everyday clinical setting. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials. [2022]