Bulimia NervosaNCT01038128
An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder
A study testing Memantine in people with Bulimia Nervosa and Body Dysmorphic Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa, Body Dysmorphic Disorder
- What is being tested?
- Memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2011
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet DSM-IV criteria for a current diagnosis of bulimia nervosa as determined by the Structured Clinical Interview for DSM-IV (SCID) and Eating Disorder Examination (EDE).
- Participants must report an average of 3 or more binges and vomiting episodes per week in the 2-week period prior to the screening visit.
- Male or Female between 18 and 65 years of age, inclusive.
- Female participants must be: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence and agreeing to continue abstinence or to use one of the acceptable methods of contraception just enumerated should sexual activity commence) before entry and throughout the study; and have a negative serum pregnancy test at the screening visit.
- Participants must have observed a designated washout period of at least seven days or a period equal to five half-lives of prohibited medications.
- Participants must be able to take oral medication, adhere to the medication regimens, and be willing to return for regular visits.
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- Participants must be able and willing to read and comprehend written instructions and comprehend and complete all scales and questionnaires required by the protocol.
- Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Inclusion criteria for participants with body dysmorphic disorder are identical to those for bulimia nervosa above, with the following differences in the first two criteria:
- Participants must meet DSM-IV criteria for a current diagnosis of body dysmorphic disorder as determined by the SCID.
- Participants must exhibit a score of ≥ 20 on the Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale (BDD-YBOCS) at a score of ≥ 5 on the first three items of the BDD-YBOCS, which are the items that assess the DSM-IV criteria for Body Dysmorphic Disorder.
- Exclusion Criteria for both Bulimia Nervosa and Body Dysmorphic Disorder:
- Participants with a lifetime diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder as defined by DSM-IV and supported by the SCID.
- Participants with clinically significant current depression or who, in the investigators' judgment, might require intervention with either pharmacological or non-pharmacological therapy for major depressive disorder over the course of the study.
- Participants judged clinically to be at suicidal or homicidal risk by the study physician.
- Participants meeting DSM-IV criteria for any form of substance dependence or abuse (with the exception of nicotine or caffeine dependence) within 3 months prior to the screening visit.
- Participants meeting DSM-IV criteria for anorexia nervosa within 3 months prior to the screening visit.
- Participants with a current DSM-IV diagnosis of an organic mental disorder.
- Participants who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy or self-guided cognitive-behavioral therapy) for bulimia nervosa within 6 months prior to the screening visit.
- Participants who display a positive urine screen for drugs of abuse (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at the screening visit.
- Participants who have previously received memantine for any reason.
- Participants who have received an investigational medication within 30 days of the screening visit.
- Participants who are pregnant or lactating.
- Participants with a body mass index (BMI) less than 18.5 or greater than 35.
- Participants who have abused ipecac as a method of purging within the past 2 years.
- Participants who exhibit a serum potassium level of less than 3.0 mEq/L.
- Participants with thyroid-stimulating hormone concentrations outside the range of 0.5-5.0 lU/mL.
- Participants with clinically significant or unstable medical conditions
- Participants who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications sections of the prescribing information for memantine
- Employees of the investigator, individuals with direct involvement in studies under the direction of the study investigators, as well as family members of the employees of the investigators.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine
The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
Read the detailed description
The primary objective of this clinical trial is to test the hypothesis that treatment with Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
We will test this hypothesis by performing a 13-week open label study investigating the use of memantine, at a dose of 10-40mg daily, as a treatment for patients with either bulimia nervosa or body dysmorphic disorder. Improvement for patients with bulimia nervosa will be assessed using the Frequency of binge eating and vomiting as recorded in diary card, Eating Disorder Evaluation (EDE), and the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS). Improvement for patients with body dysmorphic disorder will be assessed using the the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS) and Brown Assessments of Beliefs Scale. In addition both groups will also receive the Clinical Global Impression (CGI) Severity and Improvement Scales (clinician rated), Patient Global Impression of Improvement (PGI-Improvement), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Barratt Impulsiveness Scale (BIS), Version 11, Sheehan Disability Scale (SDS), and Columbia Suicide Severity Rating Scale (C-SSRS).
- Conditions
- Bulimia Nervosa, Body Dysmorphic Disorder
- Being tested
- Memantine
- Keywords
- Bulimia nervosa, Bulimia, Body dysmorphic disorder, Eating disorders, Body image, Binge eating, purging
- Medical subject headings
- Bulimia Nervosa, Body Dysmorphic Disorders, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
Drug: Memantine, 10-40 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Memantine, 10-40 mg daily Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Binge Eating and Self-induced Vomiting Episodes
Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.
Measured: Baseline to 12 weeks
Ratings of Eating Pathology
Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number "777" was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes.
Measured: Baseline to 12 weeks
Clinical Global Impression Scale
Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).
Measured: Baseline to 12 weeks
Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale
The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.
Measured: Baseline to 12 weeks
Brown Assessments of Belief Scale
The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionMay 2011
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 Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James I. Hudson, MD, Mclean Hospital
- Investigators
- James I Hudson, M.D., Sc.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038128
- Sponsor's protocol ID
- 2009-P-001901
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2009
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiglutamatergic Treatment of Bulimia Nervosa and Body Dysmorphic Disorder: An Open-Label Trial of Memantine
- ClinicalTrials.gov ID
- NCT01038128
- Acronym / sponsor ID
- 2009-P-001901
- Conditions
- Bulimia Nervosa, Body Dysmorphic Disorder
- Keywords
- Bulimia nervosa, Bulimia, Body dysmorphic disorder, Eating disorders, Body image, Binge eating, purging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Posted 12 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
Detailed description
The primary objective of this clinical trial is to test the hypothesis that treatment with Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
We will test this hypothesis by performing a 13-week open label study investigating the use of memantine, at a dose of 10-40mg daily, as a treatment for patients with either bulimia nervosa or body dysmorphic disorder. Improvement for patients with bulimia nervosa will be assessed using the Frequency of binge eating and vomiting as recorded in diary card, Eating Disorder Evaluation (EDE), and the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS). Improvement for patients with body dysmorphic disorder will be assessed using the the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS) and Brown Assessments of Beliefs Scale. In addition both groups will also receive the Clinical Global Impression (CGI) Severity and Improvement Scales (clinician rated), Patient Global Impression of Improvement (PGI-Improvement), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Barratt Impulsiveness Scale (BIS), Version 11, Sheehan Disability Scale (SDS), and Columbia Suicide Severity Rating Scale (C-SSRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: MemantineMemantine, 10-40 mg daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Participants must meet DSM-IV criteria for a current diagnosis of bulimia nervosa as determined by the Structured Clinical Interview for DSM-IV (SCID) and Eating Disorder Examination (EDE).
- Participants must report an average of 3 or more binges and vomiting episodes per week in the 2-week period prior to the screening visit.
- Male or Female between 18 and 65 years of age, inclusive.
- Female participants must be: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence and agreeing to continue abstinence or to use one of the acceptable methods of contraception just enumerated should sexual activity commence) before entry and throughout the study; and have a negative serum pregnancy test at the screening visit.
- Participants must have observed a designated washout period of at least seven days or a period equal to five half-lives of prohibited medications.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MemantineAlso: NamendaDrug: Memantine, 10-40 mg daily | Drug | Memantine |
Primary outcome
Number of Binge Eating and Self-induced Vomiting Episodes
Time frame: Baseline to 12 weeks
Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.
Ratings of Eating Pathology
Time frame: Baseline to 12 weeks
Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number "777" was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes.
Clinical Global Impression Scale
Time frame: Baseline to 12 weeks
Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).
Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale
Time frame: Baseline to 12 weeks
The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.
Brown Assessments of Belief Scale
Time frame: Baseline to 12 weeks
The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James I Hudson, M.D., Sc.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memantine in people with Bulimia Nervosa and Body Dysmorphic Disorder, run by Mclean 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 30 inclusion and 0 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 4 May 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2012). 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?
Number of Binge Eating and Self-induced Vomiting Episodes (time frame: Baseline to 12 weeks). 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?
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 4 May 2015.