Bulimia NervosaNCT00308776
Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa
A study testing Cholecystokinin (CCK) infusion and Saline infusion in people with Bulimia Nervosa and Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Eating Disorders
- What is being tested?
- Cholecystokinin (CCK) infusion and Saline infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2008
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets DSM-IV criteria for BN
- BN duration of more than 1 year
- Self-induces vomiting
- Weighs between 80 and 120% of ideal body weight
- No current or past psychiatric history
- No history of binge eating or vomiting
- 80-120% of ideal body weight
Who cannot join
- Significant medical illness
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
- Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
- History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with the study procedures
- At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
- Currently taking psychotropic medications or medications that affect gastrointestinal function
Show all 14Show fewer
- Moderate to severe depression, as defined by a score of greater than 28 on the Hamilton Depression Rating Scale
- Drug or alcohol abuse within the 3 months prior to study entry
- Pregnant, planning to become pregnant, or lactating
- Body mass index (BMI) of less than 18 (underweight)
- Significant medical illness
- Current psychotropic medications and current medications that affect GI function
- Drug or alcohol abuse in last 3 months
- Pregnancy, planning to become pregnant or laction
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
Official title: Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa.
Read the detailed description
Bulimia Nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Cholecystokinin (CCK) is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression. People with BN often have disturbances in the release of CCK, which may contribute to their binge eating behavior. This study will determine the effectiveness of administrating a dose of CCK during a binge eating episode in reducing this eating behavior in people with BN.
This study will enroll females with BN and healthy females without BN. Interested participants will first report to the study site for an interview about their feelings on their eating habits. If eligible, participants will report to the study site at 9 A.M. on 4 days. Upon arrival, they will receive a standardized breakfast of apple juice and an English muffin with butter. Participants will then return 2.5 hours later to start an IV and begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of either saline or saline plus CCK. Participants will then be given a meal of macaroni and beef. They will be alone in the room while eating, but will be monitored by TV camera. Nothing, however, will be taped or recorded. A tape recording will be used to instruct participants when to begin eating. Participants will be instructed to either eat until an assistant returns to the room, or eat as much as they can. Participants will also fill out questionnaires before and after each meal, and sometimes during a meal. The amount of food consumed after an infusion with CCK will be assessed upon study completion.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00307190
http://clinicaltrials.gov/show/NCT00304187
- Conditions
- Bulimia Nervosa, Eating Disorders
- Being tested
- Cholecystokinin (CCK) infusion, Saline infusion
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystokinin (CCK) infusionProcedure or surgery
Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK.
Saline infusionProcedure or surgery
Participants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only.
| Study group | Role | What they receive |
|---|---|---|
| Cholecystokinin | Experimental | Participants will receive intravenous saline plus cholescystokinin. Receives: Procedure: Cholecystokinin (CCK) infusion |
| Saline | Placebo comparator | Participants will receive intravenous saline only. Receives: Procedure: Saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of food consumed after administration of CCK (measured upon study completion)
Measured: Measured at Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startOct 2003
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- B. Timothy Walsh, MD, Principal investigator, New York State Psychiatric Institute at Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308776
- Sponsor's protocol ID
- #4736
- Other IDs
- DATR A2-AID
- Status last verified
- May 2012
- First submitted
- 28 Mar 2006
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT00308776
- Acronym / sponsor ID
- #4736
- Conditions
- Bulimia Nervosa, Eating Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 6 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Mar 2006 (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 study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa.
Detailed description
Bulimia Nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Cholecystokinin (CCK) is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression. People with BN often have disturbances in the release of CCK, which may contribute to their binge eating behavior. This study will determine the effectiveness of administrating a dose of CCK during a binge eating episode in reducing this eating behavior in people with BN.
This study will enroll females with BN and healthy females without BN. Interested participants will first report to the study site for an interview about their feelings on their eating habits. If eligible, participants will report to the study site at 9 A.M. on 4 days. Upon arrival, they will receive a standardized breakfast of apple juice and an English muffin with butter. Participants will then return 2.5 hours later to start an IV and begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of either saline or saline plus CCK. Participants will then be given a meal of macaroni and beef. They will be alone in the room while eating, but will be monitored by TV camera. Nothing, however, will be taped or recorded. A tape recording will be used to instruct participants when to begin eating. Participants will be instructed to either eat until an assistant returns to the room, or eat as much as they can. Participants will also fill out questionnaires before and after each meal, and sometimes during a meal. The amount of food consumed after an infusion with CCK will be assessed upon study completion.
For information on related studies, please follow these links:
http://clinicaltrials.gov/show/NCT00307190
http://clinicaltrials.gov/show/NCT00304187
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystokinin | Experimental | Procedure: Cholecystokinin (CCK) infusionParticipants will receive intravenous saline plus cholescystokinin. |
| Saline | Placebo comparator | Procedure: Saline infusionParticipants will receive intravenous saline only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meets DSM-IV criteria for BN
- BN duration of more than 1 year
- Self-induces vomiting
- Weighs between 80 and 120% of ideal body weight
- No current or past psychiatric history
Key exclusion criteria (14 listed)
- Significant medical illness
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
- Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
- History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with the study procedures
- At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
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 |
|---|---|---|
| Cholecystokinin (CCK) infusionParticipants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline plus CCK. | Procedure or surgery | Cholecystokinin |
| Saline infusionParticipants will begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of saline only. | Procedure or surgery | Saline |
Primary outcome
Amount of food consumed after administration of CCK (measured upon study completion)
Time frame: Measured at Day 4
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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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.
B. Timothy Walsh, MD principal investigator
New York State Psychiatric Institute at Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystokinin (CCK) infusion and Saline infusion in people with Bulimia Nervosa and Eating Disorders, 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 May 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. 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.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
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?
Amount of food consumed after administration of CCK (measured upon study completion) (time frame: Measured at Day 4). 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 28 May 2012.