Clinical trial

A Double-Blind, Placebo-Controlled Study of Memantine in Body Focused Repetitive Behaviors

Name
IRB20-1992
Description
This study is 8 weeks long and involves subjects taking memantine or placebo. If they are randomly assigned to the memantine arm and are eligible to participate in the study, they will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
Trial arms
Trial start
2021-06-15
Estimated PCD
2022-07-08
Trial end
2022-07-08
Status
Completed
Phase
Early phase I
Treatment
Placebo
Pill that contains no medicine
Arms:
Placebo
Other names:
no other name
Memantine
Cognition-enhancing medication
Arms:
Memantine
Other names:
Namenda
Size
100
Primary endpoint
NIMH Symptom Severity Scale (for TTM or Skin Picking)
The primary efficacy end points will be the change in these measures from baseline to week 8.
Eligibility criteria
Inclusion Criteria: 1. men and women age ≥18 years; 2. current DSM-5 trichotillomania or skin picking disorder; and 3. Ability to understand and sign the consent form. Exclusion Criteria: 1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination 2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential 3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs) 4. Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder 5. Illegal substance use based on urine toxicology screening 6. Stable dose of medications for at least the past 3 months 7. Previous treatment with memantine 8. Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-08-14

1 organization

1 product

1 drug

2 indications

Indication
Dermatillomania
Product
Memantine