Phase 2 OCD Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have signed a written consent form with a witness present.
• You are a man or woman between 18 and 65 years old.
• You are generally in good health, based on your medical history, a physical exam, blood tests, and a heart tracing (ECG).
• You have been on the same psychiatric medications for at least 4 weeks before the trial starts and do not expect any changes during the trial.
• If you are able to have children, you must agree to use an approved form of birth control during the trial and for a set period after (30 days for women, 90 days for men); people who completely abstain from sex do not need to use contraception.
• If you are a woman who could become pregnant, you must have a negative pregnancy test at multiple points throughout the trial.
• You must have negative drug screenings at multiple points during the trial (note: people on stable, prescribed doses of certain medications such as benzodiazepines, opioids, or stimulants for ADHD may still be eligible — confirm with trial site).
• You are willing and able to follow all study procedures, attend all required visits, and return for follow-up appointments.
• Your symptoms cause you noticeable distress or meaningfully interfere with your work or social life.
• Your psychiatric condition (trichotillomania/TTM) is considered stable by the study doctor.
• You have been diagnosed with trichotillomania (TTM) according to current diagnostic standards (DSM-5).
• Your hair-pulling symptoms are currently significant, scoring 12 or higher on a standard symptom scale (MGH-HPS).

Who may not be able to join:

• You have also been diagnosed with bipolar disorder, a psychotic disorder, a substance use disorder, a developmental disorder, or an intellectual disability.
• Your medications (other than psychiatric ones) have been changed, increased, decreased, or stopped within the last 4 weeks.
• You are currently taking antipsychotic medications or other medications that affect the dopamine system in the brain (confirm with trial site).
• You have recently changed or started a talking therapy/behavioral treatment for TTM or OCD within the past 4–12 weeks.
• You are taking any over-the-counter or prescription medications that may interact with the study drug, valbenazine (confirm with trial site which medications apply).
• You have a positive pregnancy test or a positive drug screening test.
• You are currently pregnant or breastfeeding.
• You have a serious medical condition alongside your mental health diagnosis (confirm with trial site).
• You use very large amounts of tobacco or nicotine products (more than 1½ packs of cigarettes per day or equivalent) within 30 days of your screening visit.
• You have had a problem with drug or alcohol misuse or dependence in the last 3 months.
• You have a known history of a serious medication reaction called neuroleptic malignant syndrome.
• You have a known history of a heart rhythm condition called long QT syndrome or other heart rhythm problems.
• Your heart tracing (ECG) shows a certain abnormal reading (QTcF greater than 450msec) or any other significant heart abnormality.
• You have lost 250mL or more of blood, donated blood in the last 56 days, or donated plasma in the last 7 days.
• You are considered to be at significant risk of suicidal thoughts or violent behavior based on your history and the doctor's assessment.
• You have a known allergy or sensitivity to the class of medications the study drug belongs to (VMAT2 inhibitors, such as tetrabenazine).
• You have a history of not following the rules of clinical research studies.
• You have previously taken valbenazine or taken part in another valbenazine study.

Important: Always verify eligibility with the trial site directly before applying.