Inositol in Trichotillomania
Condition: Trichotillomania; Hair Pulling
MeSH terms: Trichotillomania
Intervention: Inositol; Placebo
Intervention description: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.; Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Inositol; Trichotillomania; Hair Pulling; Impulse Control Disorder

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65 years

          2. Trichotillomania (TTM) as the primary psychiatric diagnosis

          3. Women's participation required negative results on a beta-human chorionic gonadotropin
             pregnancy test and stable use of a medically accepted form of contraception.

          4. Signed informed consent before entry into the study.

        Exclusion Criteria:

          1. Unstable medical illness or clinically significant abnormalities on laboratory tests
             or physical examination at screening visit

          2. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          3. A need for medication other than ecopipam with possible psychotropic effects

          4. Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as
             determined by the Structured Clinical Interview for DSM-IV

          5. Current (past 12-months) DSM-IV substance abuse or dependence

          6. Positive urine drug screen at screening

          7. Initiation of cognitive behavior therapy within 3 months prior to study baseline

          8. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS

          9. Any suicidality based on clinical interview

         10. History of head injury or neurological disorder (such as seizures)

         11. Any history of psychiatric hospitalization in the past year

         12. Any history of a suicide attempt