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Valbenazine for Trichotillomania
Study Summary
This trial is testing a new medication, valbenazine, to see if it is effective in treating trichotillomania (TTM). The trial will last for 12 weeks and will have a group of people taking valbenazine and a group taking a placebo. The primary endpoint of the trial is the change from baseline of the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores at the end of Week 12.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have a history of long QT syndrome or irregular heartbeats.My TTM symptoms are severe, scoring 17 or more.I am in good health based on recent medical exams and tests.I am currently on medication for mental health that affects dopamine.You are allergic or have a strong reaction to VMAT2 inhibitors like tetrabenazine.I have passed a drug test, or I am on stable, prescribed doses of certain medications.I am a woman and my pregnancy test was negative.My heart's electrical activity is normal, without significant abnormalities.My symptoms greatly affect my work or social life.I have not used tobacco or nicotine heavily in the last 30 days.My psychiatric medication has been stable for 4 weeks and won't change during the trial.I am not taking any medication that interacts badly with valbenazine, according to its prescription guidelines.I agree to use contraception consistently during and after the study as required.I have taken valbenazine or been in a valbenazine study before.I have a history of neuroleptic malignant syndrome.I have passed a drug test and any medication I take is prescribed and monitored.You have a history of serious mental health issues that may put you at risk for self-harm or violent behavior.I haven't changed my medication dose or stopped any medication in the last 4 weeks.I have not lost more than 250 mL of blood or donated blood in the last 56 days, nor plasma in the last 7 days.You have other mental health conditions or developmental disabilities like bipolar disorder, schizophrenia, substance abuse problems, or intellectual disability.I started or changed my OCD/TTM treatment less than 12 weeks ago.I am a woman and my pregnancy test was negative.I am between 18 and 65 years old.You meet the diagnostic criteria for Trichotillomania, as defined in the DSM-5.You have other serious health conditions that could affect your ability to participate in the study.You have struggled with drug or alcohol addiction within the past 3 months, as defined by the DSM-5 guidelines for Substance Use Disorder.
- Group 1: Valbenazine
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA recognize Valbenazine Oral Capsule as a legitimate medication?
"Although there is evidence of Valbenazine's safety, no verification of efficacy exists yet. Consequently, its safety rating on our scale stands at 2."
Who meets the eligibility criteria for this trial?
"Candidates for the trial should have trichotillomania and be between 18-65 years of age. The medical team is working to register a total of 20 participants in this study."
Is participation in this research project restricted to individuals under 40 years of age?
"The requirements to enroll in this medical study dictate that participants must be aged 18 or higher, with a cut-off of 65 years old."
Does this experiment currently accept participants?
"Info posted on clinicaltrials.gov demonstrates that this medical trial, initially launched on November 15th 2022 and most recently updated September 23rd 2022, is not currently open for recruitment. However, 6 other research studies are actively enrolling participants at the moment."
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