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| ID | Type | Description | Link |
|---|---|---|---|
| 98-09272 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.
The purpose of this study is to assess the extent of symptom remission in patients with trichotillomania following treatment with sertraline and/or behavior therapy.
Following entry into the study, subjects will undergo a washout period if they are currently taking a psychotropic medication (two weeks for psychotropic medications except for fluoxetine, which requires a four-week washout). Subjects will then be given a single-blind placebo for two weeks and assessed for symptom consistency.
Subjects will take sertraline or placebo in a double-blind design. Subjects will be assessed with the Hamilton Rating Scale for Depression (HAM-D-17), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health (NIMH) Scale, and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) at the start of the washout period and at the end of week two in order to be randomized into the study. Subject randomization to a treatment arm will be based on the random table and in equal proportions.
Subject change scores will be assessed for the above scales, and change scores for the four different treatment groups will be assessed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | |||
| Habit Reversal Training | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Scale change scores (week 2 versus 22) | Week 2 to 22 | |
| Hair Pulling Scale change scores (week 0 versus 22) | Week 0 to 22 | |
| TTM Impact Scale change scores (week 0 versus 22) | Week 0 to 22 | |
| PITS (week 0 versus 22) | Week 0 to 22 | |
| NIMH Scale (week 0 versus 22) | Week 0 to 22 |
| Measure | Description | Time Frame |
|---|---|---|
| HAM-D-17 (week 0 versus 22) | Week 0 to 22 | |
| BDI (week 0 versus 22) | Week 0 to 22 | |
| BAI (week 0 versus 22) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jenike, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital - OCD Clinic | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34582562 | Derived | Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3. |
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| ID | Term |
|---|---|
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D014256 | Trichotillomania |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Week 0 to 22 |
| Q-LES-Q (week 0 versus 22) | Week 0 to 22 |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |