What side effects are associated with this type of intervention?

Common treatments for Trichotillomania include cognitive-behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), and other pharmacological interventions. For treatments similar to Valbenazine, which is a VMAT2 inhibitor, side effects may include sedation, fatigue, dry mouth, and potential movement disorders such as tardive dyskinesia. Broadly, SSRIs can cause nausea, headache, sleep disturbances, and sexual dysfunction. It is important to discuss potential side effects with a healthcare provider to tailor the treatment to individual needs.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Trichotillomania. Treatments often involve off-label use of medications such as selective serotonin reuptake inhibitors (SSRIs) and other psychiatric medications. Valbenazine, a VMAT2 inhibitor, is currently being studied for its efficacy in treating Trichotillomania, but it has not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives to Valbenazine for Trichotillomania include the use of selective serotonin reuptake inhibitors (SSRIs) and other medications such as memantine, which has shown efficacy in related obsessive-compulsive disorders. Additionally, behavioral therapies and combination treatments involving cognitive-behavioral therapy (CBT) may also be considered.

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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Trichotillomania

Phase 2

Recruiting

Led By Michael H. Bloch, MD

Research Sponsored by Michael Bloch

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Significant current TTM symptoms: 17 or greater score on NIMH-TSS/TIS

Female subjects must have a negative urine pregnancy test at Day 1 (baseline).

Must not have

Known history of long QT syndrome or cardiac arrhythmia

Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

This trial tests the effectiveness and safety of valbenazine, a daily medication, for treating people with trichotillomania, a hair-pulling disorder. Participants will receive the medication for a certain period, followed by another period where everyone gets the medication. Valbenazine helps by balancing brain chemicals to reduce hair-pulling urges.

Who is the study for?

Adults aged 18-65 with trichotillomania (TTM) causing significant distress or impairment, who meet DSM-5 criteria for TTM and are on a stable psychiatric medication regime. Participants must be in good health, not pregnant or lactating, agree to use contraception if of child-bearing potential, have no recent drug abuse history, and no known allergies to VMAT2 inhibitors.

What is being tested?

The trial is testing the effectiveness of Valbenazine capsules at doses of 40mg or 80mg daily for treating TTM over a period of 12 weeks. It's a double-blind study where half the participants will receive Valbenazine and the other half a placebo. Afterward, there's an open-label phase where all subjects get Valbenazine.

What are the potential side effects?

While specific side effects for this trial aren't listed, common ones associated with similar medications include sleepiness, balance problems (risk of falls), nausea, headache, dry mouth and blurred vision. Serious side effects might involve heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My TTM symptoms are severe, scoring 17 or more.

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I am a woman and my pregnancy test was negative.

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My psychiatric medication has been stable for 4 weeks and won't change during the trial.

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I am a woman and my pregnancy test was negative.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of long QT syndrome or irregular heartbeats.

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I am currently on medication for mental health that affects dopamine.

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My heart's electrical activity is normal, without significant abnormalities.

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I have not used tobacco or nicotine heavily in the last 30 days.

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I have taken valbenazine or been in a valbenazine study before.

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I have a history of neuroleptic malignant syndrome.

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I started or changed my OCD/TTM treatment less than 12 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12

Secondary study objectives

Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ValbenazineExperimental Treatment1 Intervention

Participants randomized1:1 to receive valbenazine

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized 1:1 to receive placebo

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Trichotillomania include behavioral therapy and pharmacological interventions. Valbenazine, a VMAT2 inhibitor, works by regulating the release of neurotransmitters like dopamine, which can help control compulsive behaviors associated with hair-pulling. This is significant for Trichotillomania patients as it offers a targeted approach to reduce the urge to pull hair by modulating brain chemistry. Other pharmacological treatments may include SSRIs and antipsychotics, which also aim to balance neurotransmitter levels, thereby reducing compulsive behaviors. Understanding these mechanisms helps patients and clinicians make informed decisions about treatment options.