ObesityPhase 4NCT01170364
Studying the Effects of Sibutramine on Eating Behavior
A Phase 4 study testing Sibutramine in people with Obesity, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Sibutramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2010
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- moderately obese
- stable weight for a minimum of 3 months
- systolic blood pressure less than or equal to 140 mm Hg
- diastolic blood pressure less than or equal to 90 mm Hg
- pulse less than or equal to 95 beats per minute
- English language proficiency
Who cannot join
- on medications known to affect appetite, weight, or metabolism
- current or past history of: binge eating disorder, anorexia nervosa or bulimia nervosa, major depression
- current or past evidence of psychosis, bipolar illness
- current or past history of alcohol or drug abuse or dependence
- known history of learning disorder or developmental disability
- current or past attention deficit hyperactivity disorders
Show all 20Show fewer
- low platelet count
- current diabetes mellitus
- uncontrolled asthma, or controlled only with oral steroids
- hypothyroidism not adequately treated
- pregnancy, planning to become pregnant, or lactation within the previous 6 months
- history of neurological disorder or injury
- history of moderate or severe head injury
- waist circumference greater than 188 cm
- indwelling metallic object, non-removable metal jewelery, medicinal patch or recent metallic ink tattoo
- pacemaker
- metallic implants
- medication patches
- significant claustrophobia
- color blindness
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
Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions.
Read the detailed description
We will recruit 48 moderately obese men and women seeking weight-loss treatment to participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or placebo daily. At the end of weeks 1 and 3, subjects will be asked to participate in a two-day/three-night stay in the Residential Laboratory or Biological Studies Unit of the New York State Psychiatric Institute for comprehensive assessments. The major outcome variable will be the difference in total daily caloric intake between sibutramine and placebo.
Assessments will concentrate on three main components of eating behavior: eating patterns, psychological processing, and neurocognitive function. Eating behavior studies will examine objective variables such as meal size, meal frequency, and subjective aspects of eating such as hunger and fullness. Psychological studies will measure hedonics, including craving, behavioral restraint, and impulsivity. Neurocognitive function assessment will gather information about decision-making, such as the effects of distractors (food and non-food) on task performance. Additionally, drawing from the field of behavioral neuroeconomics, tasks that assess decision-making and the influence of irrational factors on decisions will be assessed. Neuroimaging (fMRI) procedures will also be conducted, and will augment the psychological and neurocognitive assessments by providing a window into the underlying neural circuitry involved.
Following the double-blind phase, participants will be offered open treatment with sibutramine for weight loss.
- Conditions
- Obesity
- Being tested
- Sibutramine, Placebo
- Keywords
- Obesity, sibutramine, eating behavior
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibutramineDrug
Also called Meridia
1 week of active sibutramine (15mg)
PlaceboDrug
Also called sugar pill
2 weeks of placebo
| Study group | Role | What they receive |
|---|---|---|
| Sibutramine | Experimental | Participants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo. Receives: Drug: Sibutramine; Drug: Placebo |
| Placebo | Experimental | Participants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine. Receives: Drug: Sibutramine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Measured Caloric Intake
The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Terminated due to sibutramine being withdrawn from the market.
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 ObesityStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Laurel Mayer, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170364
- Sponsor's protocol ID
- 5821
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2010
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effects of Sibutramine on Eating Behavior
- ClinicalTrials.gov ID
- NCT01170364
- Acronym / sponsor ID
- 5821
- Conditions
- Obesity
- Keywords
- Obesity, sibutramine, eating behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to sibutramine being withdrawn from the market.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions.
Detailed description
We will recruit 48 moderately obese men and women seeking weight-loss treatment to participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or placebo daily. At the end of weeks 1 and 3, subjects will be asked to participate in a two-day/three-night stay in the Residential Laboratory or Biological Studies Unit of the New York State Psychiatric Institute for comprehensive assessments. The major outcome variable will be the difference in total daily caloric intake between sibutramine and placebo.
Assessments will concentrate on three main components of eating behavior: eating patterns, psychological processing, and neurocognitive function. Eating behavior studies will examine objective variables such as meal size, meal frequency, and subjective aspects of eating such as hunger and fullness. Psychological studies will measure hedonics, including craving, behavioral restraint, and impulsivity. Neurocognitive function assessment will gather information about decision-making, such as the effects of distractors (food and non-food) on task performance. Additionally, drawing from the field of behavioral neuroeconomics, tasks that assess decision-making and the influence of irrational factors on decisions will be assessed. Neuroimaging (fMRI) procedures will also be conducted, and will augment the psychological and neurocognitive assessments by providing a window into the underlying neural circuitry involved.
Following the double-blind phase, participants will be offered open treatment with sibutramine for weight loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sibutramine | Experimental | Drug: Sibutramine, Drug: PlaceboParticipants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo. |
| Placebo | Experimental | Drug: Sibutramine, Drug: PlaceboParticipants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- moderately obese
- stable weight for a minimum of 3 months
- systolic blood pressure less than or equal to 140 mm Hg
- diastolic blood pressure less than or equal to 90 mm Hg
- pulse less than or equal to 95 beats per minute
Key exclusion criteria (20 listed)
- on medications known to affect appetite, weight, or metabolism
- current or past history of: binge eating disorder, anorexia nervosa or bulimia nervosa, major depression
- current or past evidence of psychosis, bipolar illness
- current or past history of alcohol or drug abuse or dependence
- known history of learning disorder or developmental disability
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 |
|---|---|---|
| SibutramineAlso: Meridia1 week of active sibutramine (15mg) | Drug | Placebo, Sibutramine |
| PlaceboAlso: sugar pill2 weeks of placebo | Drug | Placebo, Sibutramine |
Primary outcome
24 Hour Measured Caloric Intake
Time frame: 1 week
The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- 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.
Laurel Mayer, M.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sibutramine in people with Obesity, 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 6 inclusion and 20 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 30 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2017). 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?
24 Hour Measured Caloric Intake (time frame: 1 week). 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 30 Aug 2017.