Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

Skin-Picking Clinical Trial

Official title:

Single-Group Crossover Trial Comparing Behavioral Treatment to Memantine in Body Focused Repetitive Behaviors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796752
• Other study ID #: IRB23-0033
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: Madison Collins, BA
• Phone: 7738343778
• Email: mcollins4[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the proposed study is to compare the efficacy of behavioral treatment (BT) to memantine, a psychopharmacological agent, for BFRBs. 28 subjects with trichotillomania (TTM) or skin picking disorder (SPD) will receive 8 weeks of memantine treatment, followed by 8 weeks of comprehensive behavioral therapy (ComB) treatment. The hypothesis to be tested is that behavioral therapy will be associated with superior clinical outcomes as compared to memantine. A second hypothesis is that both memantine and behavioral therapy will demonstrate improvement from baseline to the respective posttreatment assessment.

Description:

Hair pulling disorder (i.e., trichotillomania, TTM) and skin picking disorder (SPD) are often categorized under the umbrella term of BFRB disorders. These repetitive, intentionally performed behaviors often cause noticeable cosmetic issues and may result in clinically significant distress or functional impairment.

Behavioral therapy (BT) is generally regarded as the first-line treatment for BFRBs. One type of BT is comprehensive behavioral treatment (ComB), a treatment that emphasizes habit reversal training and various techniques that target specific BFRB triggers (e.g., sensory cues, such as pressure on the scalp; environmental cues, such as bright lights and mirrors), including emotion dysregulation. The ComB protocol was methodically developed based on expert consensus and demonstrated promising results in one single case design study and a randomized controlled trial comparing it to a minimal attention control condition.

Research has also found benefit of pharmacological agents in the treatment of BFRBs. Most recently, a randomized controlled trial of memantine vs. placebo found statistically significant improvements in disorder severity and life functioning in the memantine group as compared to the placebo group.

Although there are emerging behavioral and psychopharmacological interventions for BFRBs, the research is limited. Additionally, there are no studies comparing the efficacy of first-line behavioral treatments to promising medication interventions for this class of disorders. Given the serious personal consequences associated with trichotillomania and skin picking disorder, there is substantial need for additional research to clarify the best available treatments for BFRBs. Doing so would facilitate future research and the development of refined treatment guidelines. Therefore, the current trial aims to compare the efficacy of behavioral therapy and memantine in adults with trichotillomania and skin picking disorder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women ages 18+

• Current DSM-5 diagnosis of trichotillomania (TTM) or skin picking disorder (SPD)

• Ability to understand and sign the consent form

• Stable dose of medications for at least the past 3 months

Exclusion Criteria:

• Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination

• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

• Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)

• Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder

• Illegal substance use based on urine toxicology screening

• Previous treatment with memantine

• Previous trial of ComB or similar BT protocol (e,g., habit reversal training)

• Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Related Conditions & MeSH terms

• Skin-Picking
• Trichotillomania
• Trichotillomania (Hair-Pulling Disorder)

Intervention

Drug:
• Memantine
Cognition-enhancing medication

Behavioral:
• ComB Behavioral Therapy
Therapy for BFRBs

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bottesi G, Ouimet AJ, Cerea S, Granziol U, Carraro E, Sica C, Ghisi M. Comprehensive Behavioral Therapy of Trichotillomania: A Multiple-Baseline Single-Case Experimental Design. Front Psychol. 2020 Jun 10;11:1210. doi: 10.3389/fpsyg.2020.01210. eCollection 2020. — View Citation

Carlson EJ, Malloy EJ, Brauer L, Golomb RG, Grant JE, Mansueto CS, Haaga DAF. Comprehensive Behavioral (ComB) Treatment of Trichotillomania: A Randomized Clinical Trial. Behav Ther. 2021 Nov;52(6):1543-1557. doi: 10.1016/j.beth.2021.05.007. Epub 2021 Jun 3. — View Citation

Falkenstein MJ, Mouton-Odum S, Mansueto CS, Golomb RG, Haaga DA. Comprehensive Behavioral Treatment of Trichotillomania: A Treatment Development Study. Behav Modif. 2016 May;40(3):414-38. doi: 10.1177/0145445515616369. Epub 2015 Dec 7. — View Citation

Farhat LC, Olfson E, Nasir M, Levine JLS, Li F, Miguel EC, Bloch MH. Pharmacological and behavioral treatment for trichotillomania: An updated systematic review with meta-analysis. Depress Anxiety. 2020 Aug;37(8):715-727. doi: 10.1002/da.23028. Epub 2020 May 10. — View Citation

Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432. — View Citation

Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508. — View Citation

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available. — View Citation

HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available. — View Citation

Keuthen NJ, O'Sullivan RL, Ricciardi JN, Shera D, Savage CR, Borgmann AS, Jenike MA, Baer L. The Massachusetts General Hospital (MGH) Hairpulling Scale: 1. development and factor analyses. Psychother Psychosom. 1995;64(3-4):141-5. doi: 10.1159/000289003. — View Citation

Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1. — View Citation

Swedo SE, Leonard HL, Rapoport JL, Lenane MC, Goldberger EL, Cheslow DL. A double-blind comparison of clomipramine and desipramine in the treatment of trichotillomania (hair pulling). N Engl J Med. 1989 Aug 24;321(8):497-501. doi: 10.1056/NEJM198908243210803. — View Citation

Woods DW, Flessner CA, Franklin ME, Keuthen NJ, Goodwin RD, Stein DJ, Walther MR; Trichotillomania Learning Center-Scientific Advisory Board. The Trichotillomania Impact Project (TIP): exploring phenomenology, functional impairment, and treatment utilization. J Clin Psychiatry. 2006 Dec;67(12):1877-88. doi: 10.4088/jcp.v67n1207. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS)	The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score on the NIMH Symptom Severity Scale (for Trichotillomania or Skin Picking). The primary endpoints will be used to examine differential improvements for memantine vs. BT. Total scores on the NIMH-TSS and NIMH-SPS range from 0-20, with higher scores representing greater severity of trichotillomania/skin picking.	The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.
Secondary	Clinical Global Impressions -- Improvement Scale (CGI-I)	A clinician-rated measure to assess global improvement in symptoms. The scale ranges from 1 (Very much improved) to 7 (Very much worse). The results will be dichotomized as improved (CGI-I score of 1 or 2) or not improved (CGI-I score of 3-7). The scale will be assessed at the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Massachusetts General Hospital Hairpulling Scale (MGH-HPS)	Brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of trichotillomania (TTM).The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Massachusetts General Hospital Hairpulling Scale -- Revised for Skin Picking	Brief, self-report instrument for assessing repetitive skin picking. Seven individual items, rated for severity from 0 to 4, assess urges to pick, actual picking, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of skin picking disorder. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Quality of Life Inventory	A self-report assessment of patient perceived quality of life. Quality of Life Inventory t-scores range from 1-77. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Sheehan Disability Scale (SDS)	A self-report measure of functional impairment from TTM or SPD. SDS total scores range from 0-30. Higher scores indicate greater functional impairment. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	A clinician-administered assessment of anxiety. HAM-A total scores range from 0-56. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Hamilton Depression Rating Scale (HAM-D)	A clinician-administered assessment of depression. HAM-D total scores range from 0-52. Higher scores indicate higher levels of depression, with 0 being no symptoms of depression. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks
Secondary	Barratt Impulsiveness Scale (BIS)	A self-report assessment of impulsivity. BIS total scores range from 30-120. Higher total scores indicate higher impulsiveness. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.	20 weeks