Valbenazine for Trichotillomania
Recruiting in Palo Alto (17 mi)
Overseen byMichael H. Bloch, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Michael Bloch
Must not be taking: Antipsychotics, Psychostimulants
Disqualifiers: Bipolar, Psychotic, Substance use, others
Prior Safety Data
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable psychiatric medication regime for at least 4 weeks before starting and do not anticipate changes during the trial. If you are taking medications that might interact with valbenazine, you may need to stop those, but the protocol does not specify all medications that must be stopped.
How is the drug Valbenazine unique in treating trichotillomania?
Valbenazine is unique for trichotillomania as it is primarily used for treating movement disorders like tardive dyskinesia, and its mechanism involves modulating dopamine, a brain chemical linked to movement and behavior. This differs from other treatments like risperidone or fluoxetine, which are more commonly used for psychiatric conditions and may not directly target the same pathways.
12345Eligibility Criteria
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.Inclusion Criteria
My TTM symptoms are severe, scoring 17 or more.
I am in good health based on recent medical exams and tests.
I have passed a drug test, or I am on stable, prescribed doses of certain medications.
+12 more
Exclusion Criteria
I have a history of long QT syndrome or irregular heartbeats.
I am currently on medication for mental health that affects dopamine.
You are allergic or have a strong reaction to VMAT2 inhibitors like tetrabenazine.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive valbenazine or placebo for 12 weeks with dose titration to optimal levels
12 weeks
6 visits (in-person, every 2 weeks)
Open-label Extension
All participants receive open-label valbenazine for 12 weeks at their optimal dose
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
1 visit (in-person)
Participant Groups
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.
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
Valbenazine is already approved in United States for the following indications:
🇺🇸 Approved in United States as Ingrezza for:
- Tardive dyskinesia
- Chorea associated with Huntington's disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Child Study CenterNew Haven, CT
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Who Is Running the Clinical Trial?
Michael BlochLead Sponsor
Yale UniversityLead Sponsor
Neurocrine BiosciencesIndustry Sponsor
References
Reversal of trichotillomania with aripiprazole. [2018]Trichotillomania (TTM) is a common psychiatric illness with marked chronicity and comorbidity that significantly impacts on psychosocial functioning and physical features of the sufferer. Treatment studies, to date, using behavioral and pharmacological interventions alone or simultaneously, are equivocal with few showing a sustained cessation of hair-plucking. In this report of a single patient with treatment resistant TTM, the sole use of the atypical neuroleptic Aripiprazole resulted in a cessation of hair-plucking maintained, at the time of reporting, for a period of 24 months. This finding, a first with Aripiprazole, warrants further investigation of this drug in the treatment of TTM.
An open-label pilot study of naltrexone in childhood-onset trichotillomania. [2013]This pilot open study evaluates the safety and efficacy of naltrexone in the management of patients with childhood onset trichotillomania (TTM).
Olanzapine is effective in the management of some self-induced dermatoses: three case reports. [2018]Self-inflicted dermatoses are often difficult to treat. We present three patients with excoriated acne, self-induced skin ulcers, and trichotillomania, respectively, whose symptoms responded favorably to a 2- to 4-week course of the atypical antipsychotic olanazpine at a dosage of 2.5 to 5.0 mg daily. In two of three patients, the efficacy of the olanzapine was most likely related to an attenuation of dissociative symptoms that were associated with the self-induced skin ulcers and trichotillomania.
Risperidone addition in serotonin reuptake inhibitor-resistant trichotillomania: three cases. [2022]Open-label addition of a low-dose typical (pimozide) neuroleptic was shown to be beneficial in some patients with serotonin reuptake inhibitor (SRI)-refractory trichotillomania (TTM). Risperidone's potentially more benign acute and long-term side effect profile makes it a candidate for investigation in the treatment of TTM. We report our experience with the systematic addition of open-label risperidone 0.5 to 3 mg/day in three patients with SRI-refractory TTM. All three patients had a robust decrease in hair pulling as measured by clinician-rated instruments. These results suggest that risperidone addition to ongoing treatment with SRIs may be an effective treatment strategy for patients with SRI-refractory TTM.
Fluoxetine treatment of trichotillomania and depression in a prepubertal child. [2013]The case of a ten-year-old boy with a two-year history of trichotillomania and depression is presented. Imipramine was unsuccessful in treating trichotillomania and showed limited success in alleviating depression. Treatment with low-dosage fluoxetine (10 mg daily) led to marked improvement of both trichotillomania and depression.