A Study in Patients With Trichotillomania (NCT03797521) | Clinical Trial Compass
CompletedPhase 2
A Study in Patients With Trichotillomania
United States128 participantsStarted 2018-12-19
Plain-language summary
The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 when dosed for 6 weeks versus placebo in adult patients with moderate to severe Trichotillomania.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult, female or male, 18-45 years of age, inclusive at screening.
. Provided signed written informed consent with willingness and ability to comply with all aspects of the protocol.
. Diagnosis of current TTM based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria and confirmed using the clinician-administered MINI-TTM. In addition, subjects should:
. Have a history of TTM for at least one year
. Have a history of daily hair pulling for at least 6 months prior to the first dose
. Except for SSRIs or SNRIs, has not used any psychoactive medications including, but not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics, benzodiazepines, stimulants, sulfasalazine, and St. John's Wort 30 days prior to first dose. Subjects will be allowed to maintain background therapy with SSRIs or SNRIs if on stable regimen for a minimum of 90 days prior to first dose and there are no anticipated changes to the SSRI/SNRI during course of trial.
. Has not used N-acetylcysteine for at least 90 days prior to the first dose.
. Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM
. Females who are pregnant or breastfeeding or intend to become pregnant during the study period or within 30 days of the final dose of study drug.
. Subjects engaged in cognitive behavioral therapy (CBT) for TTM or other body-focused repetitive behavior or any obsessive-compulsive related or impulse control disorder any time within 60 days prior to first dose. For other psychotherapies, subject must have been engaged in that psychotherapy for a minimum of 60 days at the time of first dose and must be willing to maintain the same frequency and type of therapy for the duration of the study period.
. Subjects engaged in any other behavioral interventions (e.g., wearable devices, behavioral self-help strategies) within 60 days prior to first dose.
. Mentally or legally incompetent.
. Suffered a concussion in the past 6 months prior to screening. Any history of traumatic brain injury with loss of consciousness in the year prior to first screening visit.
. Any lifetime history of any psychotic disorder, including schizophrenia or any bipolar or bipolar-related disorder as determined by clinical history or confirmed at screening with the MINI, version 7.0.2.
. Current major depressive episode confirmed at screening with the MINI, version 7.0.2.
. Per PI judgment, the presence of any emotional problems or psychiatric disorders that may obscure evaluation of primary TTM or pose a risk to subject safety or stability during the study period. Other emotional problems or diagnoses may include, but are not limited to, other body-focused repetitive behaviors, post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder, compulsive gambling, borderline personality disorder, or antisocial personality disorder.