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Impulse Control DisordersPhase 4NCT00118014

Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

A Phase 4 study testing Sertraline and Habit Reversal Training in people with Impulse Control Disorders, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Impulse Control Disorders
What is being tested?
Sertraline and Habit Reversal Training
How many people
75 participants
Where
1 siteUnited States
Study dates
Jan 2000to Aug 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will have a DSM-IV diagnosis of TTM.
  • TTM symptoms for at least 4 months.
  • Scalp as primary site of hair pulling.
  • HPS score greater than or equal to 15 OR TTM Impact Scale score greater than 30.
  • Written informed consent.
  • Men or women aged 18-65 years old.
  • Females of childbearing potential must have a negative serum beta-HCG pregnancy test.

Who cannot join

  • Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
  • Patients who, in the investigator's judgement, pose a serious suicidal or homicidal risk.
  • Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
  • History of seizure disorder.
  • Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder.
  • If there is a history of substance abuse, patients must be in remission at least 6 months.
Show all 9Show fewer
  • Past trials of sertraline.
  • Currently being treated with behavioral therapy, specifically habit reversal training, for TTM.
  • Other medications for medical disorders that may interact with sertraline.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital - OCD Clinic

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Sertraline, Habit Reversal Training
Keywords
Trichotillomania, Habit Reversal Training, Sertraline, Zoloft
Medical subject headings
Disruptive, Impulse Control, and Conduct Disorders, Trichotillomania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Global Impressions Scale change scores (week 2 versus 22)

    Measured: Week 2 to 22

  2. Hair Pulling Scale change scores (week 0 versus 22)

    Measured: Week 0 to 22

  3. TTM Impact Scale change scores (week 0 versus 22)

    Measured: Week 0 to 22

  4. PITS (week 0 versus 22)

    Measured: Week 0 to 22

  5. NIMH Scale (week 0 versus 22)

    Measured: Week 0 to 22

Secondary outcomes (4)

  1. HAM-D-17 (week 0 versus 22)

    Measured: Week 0 to 22

  2. BDI (week 0 versus 22)

    Measured: Week 0 to 22

  3. BAI (week 0 versus 22)

    Measured: Week 0 to 22

  4. Q-LES-Q (week 0 versus 22)

    Measured: Week 0 to 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2005 (estimated)
  2. Study startJan 2000
  3. Primary completionApr 2004
  4. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118014
Sponsor's protocol ID
1999-P-003152
Other IDs
98-09272
Status last verified
May 2008
First submitted
1 Jul 2005
Last updated
20 May 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34582562

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sertraline and Habit Reversal Training in people with Impulse Control Disorders, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impressions Scale change scores (week 2 versus 22) (time frame: Week 2 to 22). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00118014, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.

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