Anorexia NervosaNCT00755820
Food Exposure Therapy in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Exposure Therapy + D-Cycloserine and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2012
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Inpatients receiving treatment for anorexia nervosa
Who may be able to join
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype) on admission
- Subjects will have achieved 90% of ideal body weight (IBW)
- Age 18-45
- Medically stable
- Participation in inpatient treatment
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
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- BMI ≥ 19.0 kg/m2
- Age 18-45 years
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Any other current major Axis I disorder, except OCD or MDD (mild)
- On psychotropic medication, including benzodiazepines (At the start of the study, subjects will be free of fluoxetine for 4 weeks, and free of all other medications for a minimum of 2 weeks.)
- History of a seizure disorder
- Abnormal liver function
- Renal insufficiency
- Known hypersensitivity to D-cycloserine
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- Pregnant or lactating
- Acute suicidality (suicidality or self injury in the last 3 months)
- Current Major Axis I disorder (including Eating Disorder, Major Depression,Bipolar Disorder, Schizophrenia, Substance Abuse/Dependence) History of an Eating Disorder
- Current use of psychotropic medication or other medication known to affect mood and/or anxiety (e.g. b-agonist inhalers, oral steroids)
- Major medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa.
Read the detailed description
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa. DCS is approved by the FDA as an antibiotic medication, but has not been approved by the FDA for the treatment of anorexia nervosa. Past studies have found that DCS together with Exposure Therapy can help people with height phobia, social phobia, and obsessive compulsive disorder. Anorexia nervosa often includes phobia-like fears, obsessive thoughts, and compulsive rituals, so the current study aims to determine whether DCS paired with Exposure Therapy can also help people with anorexia nervosa. Anorexia nervosa is a disorder characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. You have been asked to participate in this study because you have been given a diagnosis of anorexia nervosa. In this study you will receive one of three therapies: Exposure Therapy with DCS, Exposure Therapy with placebo (inactive medication), or Treatment as Usual. You will participate in a total of four test meals in a laboratory setting. A total of 70 individuals with anorexia nervosa will participate in this study. Twenty individuals who have never had an eating disorder will participate in one portion of this study.
- Conditions
- Anorexia Nervosa
- Being tested
- Exposure Therapy + D-Cycloserine, Exposure Therapy + Placebo, Supportive Psychotherapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Therapy + D-CycloserineBehavioural
Exposure therapy with d-cycloserine medication
Exposure Therapy + PlaceboBehavioural
Exposure therapy with placebo medication
Supportive PsychotherapyBehavioural
Supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| EXP-DCS/Exposure-D-cycloserine | Exposure Therapy + D-Cycloserine Receives: Behavioral: Exposure Therapy + D-Cycloserine | |
| EXP-PBO | Exposure Therapy + Placebo Receives: Behavioral: Exposure Therapy + Placebo | |
| SP | Supportive psychotherapy Receives: Behavioral: Supportive Psychotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation, National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Joanna Steinglass, M.D., Principal investigator, CUMC/NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755820
- Sponsor's protocol ID
- 5457
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinglass JE, Sysko R, Mayer L, Berner LA, Schebendach J, Wang Y, Chen H, Albano AM, Simpson HB, Walsh BT. Pre-meal anxiety and food intake in anorexia nervosa. Appetite. 2010 Oct;55(2):214-8. doi: 10.1016/j.appet.2010.05.090. Epub 2010 Jun 4.
PubMed 20570701
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Exposure Therapy in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00755820
- Acronym / sponsor ID
- 5457
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation, National Alliance for Research on Schizophrenia and Depression
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa.
Detailed description
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa. DCS is approved by the FDA as an antibiotic medication, but has not been approved by the FDA for the treatment of anorexia nervosa. Past studies have found that DCS together with Exposure Therapy can help people with height phobia, social phobia, and obsessive compulsive disorder. Anorexia nervosa often includes phobia-like fears, obsessive thoughts, and compulsive rituals, so the current study aims to determine whether DCS paired with Exposure Therapy can also help people with anorexia nervosa. Anorexia nervosa is a disorder characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. You have been asked to participate in this study because you have been given a diagnosis of anorexia nervosa. In this study you will receive one of three therapies: Exposure Therapy with DCS, Exposure Therapy with placebo (inactive medication), or Treatment as Usual. You will participate in a total of four test meals in a laboratory setting. A total of 70 individuals with anorexia nervosa will participate in this study. Twenty individuals who have never had an eating disorder will participate in one portion of this study.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EXP-DCS/Exposure-D-cycloserine | – | Behavioral: Exposure Therapy + D-CycloserineExposure Therapy + D-Cycloserine |
| EXP-PBO | – | Behavioral: Exposure Therapy + PlaceboExposure Therapy + Placebo |
| SP | – | Behavioral: Supportive PsychotherapySupportive psychotherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Inpatients receiving treatment for anorexia nervosa
Key inclusion criteria (9 listed)
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype) on admission
- Subjects will have achieved 90% of ideal body weight (IBW)
- Age 18-45
- Medically stable
- Participation in inpatient treatment
Key exclusion criteria (11 listed)
- Any other current major Axis I disorder, except OCD or MDD (mild)
- On psychotropic medication, including benzodiazepines (At the start of the study, subjects will be free of fluoxetine for 4 weeks, and free of all other medications for a minimum of 2 weeks.)
- History of a seizure disorder
- Abnormal liver function
- Renal insufficiency
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 |
|---|---|---|
| Exposure Therapy + D-CycloserineExposure therapy with d-cycloserine medication | Behavioural | EXP-DCS/Exposure-D-cycloserine |
| Exposure Therapy + PlaceboExposure therapy with placebo medication | Behavioural | EXP-PBO |
| Supportive PsychotherapySupportive psychotherapy | Behavioural | SP |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Derived from this study: PubMed 20570701Steinglass JE, Sysko R, Mayer L, Berner LA, Schebendach J, Wang Y, Chen H, Albano AM, Simpson HB, Walsh BT. Pre-meal anxiety and food intake in anorexia nervosa. Appetite. 2010 Oct;55(2):214-8. doi: 10.1016/j.appet.2010.05.090. Epub 2010 Jun 4.
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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.
Joanna Steinglass, M.D. principal investigator
CUMC/NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by New York State Psychiatric Institute 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 9 inclusion and 11 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 26 Oct 2012. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755820, 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 26 Oct 2012.