Body Dysmorphic DisorderEarly Phase 1BDD/DCSNCT00842309

D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder

A Early Phase 1 study testing d-cycloserine in people with Body Dysmorphic Disorder, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Body Dysmorphic Disorder
What is being tested?: d-cycloserine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Aug 2018
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age or older
Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
Females of childbearing potential must have a negative urinary beta-HCG test
Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures

Who cannot join

Pregnant or breastfeeding women will be excluded
People taking medications that may interfere with DCS
History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
Those deemed to pose a serious suicidal or homicidal threat will be excluded
Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder

The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.

Conditions: Body Dysmorphic Disorder
Being tested: d-cycloserine, Placebo
Medical subject headings: Body Dysmorphic Disorders

What participants receive

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

d-cycloserineDrug
Also called seromycin
100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
PlaceboDrug
Also called sugar pill
Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Study groups in NCT00842309
Study group	Role	What they receive
D-cycloserine	Active comparator	100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Receives: Drug: d-cycloserine
Placebo	Placebo comparator	Placebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks. Receives: Drug: Placebo

What is being measured

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

Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Measured: Endpoint (post-treatment, week 11)
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Measured: Mid-treatment (week 6)

Timeline

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

Nov 2008Aug 2018

First posted12 Feb 2009 (estimated)
Study startNov 2008
Primary completionDec 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00842309
Sponsor's protocol ID: 2008P001429
Acronym: BDD/DCS
Status last verified: Jun 2019
First submitted: 10 Feb 2009
Last updated: 18 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
ClinicalTrials.gov ID: NCT00842309
Acronym / sponsor ID: BDD/DCS / 2008P001429
Conditions: Body Dysmorphic Disorder
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Nov 2008
Primary completion: Dec 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 12 Feb 2009 (estimated)
Results: Posted 15 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
D-cycloserine	Active comparator	Drug: d-cycloserine100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years of age or older
Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
Females of childbearing potential must have a negative urinary beta-HCG test
Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures

Key exclusion criteria (7 listed)

Pregnant or breastfeeding women will be excluded
People taking medications that may interfere with DCS
History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
d-cycloserineAlso: seromycin100mg of d-cycloserine in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.	Drug	D-cycloserine
PlaceboAlso: sugar pillPlacebo in pill form administered 1 hour before behavior therapy sessions once a week for 8 weeks.	Drug	Placebo

Primary outcome

Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Time frame: Endpoint (post-treatment, week 11)
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.
Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
Time frame: Mid-treatment (week 6)
The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess BDD symptoms at baseline and endpoint.

Results and safety

Results posted to the registry on 15 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
D-cycloserine-augmented CBT	14	11
Placebo-augmented CBT	14	13

Primary outcome: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

Time frame: Endpoint (post-treatment, week 11). Mean (Standard Deviation). Unit: units on a scale

Measure	D-cycloserine n = 11	Placebo n = 13
Value	19.64 (6.8)	18.77 (10.03)

Population analysed: BDD-YBOCS was a clinician-administered measure administered to patients with body dysmorphic disorder.

Primary outcome: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)

Time frame: Mid-treatment (week 6). Mean (Standard Deviation). Unit: units on a scale

Measure	D-cycloserine n = 12	Placebo n = 13
Value	21.75 (5.34)	20.85 (8.9)

Adverse events

Time frame: Adverse event data was collected at pretreatment, mid-treatment, post-treatment and at 1- and 6- month follow-up visits.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D-cycloserine-augmented CBT	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14
Placebo-augmented CBT	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mass General Hospital BDD clinic websiteLink provided by the sponsor.
OCD and Related Disorders Clinic at MGHLink provided by the sponsor.

Related trials for Body Dysmorphic Disorder

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sabine Wilhelm, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing d-cycloserine in people with Body Dysmorphic Disorder, 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 5 inclusion and 7 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 18 Jun 2019. 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) (time frame: Endpoint (post-treatment, week 11)). The study lists 2 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 NCT00842309.

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 18 Jun 2019.