Inositol in Trichotillomania (NCT01875445) | Clinical Trial Compass
CompletedPhase 2
Inositol in Trichotillomania
United States38 participantsStarted 2013-05
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of inositol for the treatment of compulsive hair pulling, also known as trichotillomania. Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical treatment with some medications, including lithium. The hypothesis to be tested is that Inositol will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of the disabling disorder that currently lacks a clearly effective treatment.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18-65 years
✓. Trichotillomania (TTM) as the primary psychiatric diagnosis
✓. Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
✓. Signed informed consent before entry into the study.
Exclusion criteria
✕. Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
✕. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
✕. A need for medication other than ecopipam with possible psychotropic effects
✕. Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
✕. Current (past 12-months) DSM-IV substance abuse or dependence
What they're measuring
1
The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)
Timeframe: Once every two weeks for the 10 weeks of the study