Binge-Eating DisorderPhase 2NCT01921582
A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
A Phase 2 study testing Methylphenidate and Cognitive Behavioral Therapy in people with Binge-Eating Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Methylphenidate and Cognitive Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Sep 2015
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Binge-Eating Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Body Mass Index ≥ 25
- Must be fluent in English
- Must be capable to give informed consent
Who cannot join
- Current pregnancy or lactation
- Psychotherapy or behavioural treatment for eating or weight initiated during the past month
- Psychotropic or investigational medications initiated / changed during the past three months
- Concomitant use of another psychostimulant
- Current mental disorders that are acute/unstable, that require alternate treatment, and/or that preclude ability to complete research protocol including mania, psychosis, substance use (alcohol or drugs), dementia, organic brain disorders, mental retardation
- Current severe suicidality or homicidality
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- Current uncontrolled medical conditions that affect weight or BED symptoms or that are contraindicated for methylphenidate including metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine diseases
- Other serious medical illness or event such as acute myocardial infarction or stroke during the past six months
- History of seizures or tics in the past year
- Diagnosis or family history of Tourette's
- Clinically relevant laboratory results, including: Tachycardia as indicated by heart rate > 110; Hypertension as indicated by blood pressure parameters > 140 (systolic) and 90 (diastolic); Arrhythmias or conduction abnormalities as indicated by ECG parameters QTC> 460msec, QRS>120 msec, and PR>200 msec; Abnormal laboratory results (e.g., hypokalemia) as indicated by values > 20% above the upper range of the laboratory standard of a basic metabolic screen
- Current medications that affect weight
- Current medications that are contraindicated for methylphenidate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder
The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females.
Read the detailed description
Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy. Participants will complete interviewer-rated and self-report measures of eating, mood, attention, and personality features before treatment, after 6 weeks of treatment, immediately after treatment is completed, and 3 months after treatment is completed.
- Conditions
- Binge-Eating Disorder
- Being tested
- Methylphenidate, Cognitive Behavioral Therapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called TEVA-METHYLPHENIDATE ER-C
- Weekly appointments with study psychiatrists for the first four weeks, and then biweekly appointments for the last eight weeks.
- Intervention will consist of medication as well as components of "Med-Plus" treatment (e.g., medication management, general support, and compliance enhancement strategies).
Cognitive Behavioral TherapyBehavioural
Cognitive Behavior Therapy will include three phases:
- Phase 1 undertakes to eliminate binge episodes and introduce a 'regular' pattern of eating;
- Phase 2 aims to reduce food intake and restructure eating-related cognitions;
- Phase 3 focuses upon relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Methylphenidate (TEVA-METHYLPHENIDATE ER-C)
* Dosage: 18 mg/day at Week 1; 36 mg/day at Week 2; 54 mg/day at Week 3; 72 mg/day at Week 4. Dosage levels may be maintained or decreased to manage medication side effects.
* Dosage form: tablet
* Dosage frequency: daily
* Duration: 12 weeks total Receives: Drug: Methylphenidate |
| Cognitive Behavioral Therapy | Active comparator | Cognitive Behavioral Therapy
* 12 individual 50-minute appointments over the course of up to 14 weeks
* According to Fairburn, Marcus, and Wilson (1993) Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of binge episodes/days, as assessed by prospective daily binge diary
Measured: After 12 weeks of treatment
Secondary outcomes (5)
Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire
Measured: After 12 weeks of treatment
Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
Measured: After 12 weeks of treatment
Quality of life, as assessed by the Quality of Life Inventory
Measured: After 12 weeks of treatment
Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
Measured: After 12 weeks of treatment
Body Mass Index
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C Quilty, PhD, Principal investigator, Centre for Addiction and Mental HealthAllan S Kaplan, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921582
- Sponsor's protocol ID
- 044/2013
- Status last verified
- Feb 2017
- First submitted
- 7 Aug 2013
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT01921582
- Acronym / sponsor ID
- 044/2013
- Conditions
- Binge-Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 2013 (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.
The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females.
Detailed description
Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy. Participants will complete interviewer-rated and self-report measures of eating, mood, attention, and personality features before treatment, after 6 weeks of treatment, immediately after treatment is completed, and 3 months after treatment is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateMethylphenidate (TEVA-METHYLPHENIDATE ER-C) * Dosage: 18 mg/day at Week 1; 36 mg/day at Week 2; 54 mg/day at Week 3; 72 mg/day at Week 4. Dosage levels may be maintained or decreased to manage medication side effects. * Dosage form: tablet * Dosage frequency: daily * Duration: 12 weeks total |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy * 12 individual 50-minute appointments over the course of up to 14 weeks * According to Fairburn, Marcus, and Wilson (1993) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Binge-Eating Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Body Mass Index ≥ 25
- Must be fluent in English
- Must be capable to give informed consent
Key exclusion criteria (13 listed)
- Current pregnancy or lactation
- Psychotherapy or behavioural treatment for eating or weight initiated during the past month
- Psychotropic or investigational medications initiated / changed during the past three months
- Concomitant use of another psychostimulant
- Current mental disorders that are acute/unstable, that require alternate treatment, and/or that preclude ability to complete research protocol including mania, psychosis, substance use (alcohol or drugs), dementia, organic brain disorders, mental retardation
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 |
|---|---|---|
| MethylphenidateAlso: TEVA-METHYLPHENIDATE ER-C* Weekly appointments with study psychiatrists for the first four weeks, and then biweekly appointments for the last eight weeks. * Intervention will consist of medication as well as components of "Med-Plus" treatment (e.g., medication management, general support, and compliance enhancement strategies). | Drug | Methylphenidate |
| Cognitive Behavioral TherapyCognitive Behavior Therapy will include three phases: * Phase 1 undertakes to eliminate binge episodes and introduce a 'regular' pattern of eating; * Phase 2 aims to reduce food intake and restructure eating-related cognitions; * Phase 3 focuses upon relapse prevention | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Frequency of binge episodes/days, as assessed by prospective daily binge diary
Time frame: After 12 weeks of treatment
5 secondary outcomes
Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire
Time frame: After 12 weeks of treatment
Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale
Time frame: After 12 weeks of treatment
Quality of life, as assessed by the Quality of Life Inventory
Time frame: After 12 weeks of treatment
Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale
Time frame: After 12 weeks of treatment
Body Mass Index
Time frame: After 12 weeks of treatment
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 6 Feb 2017.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lena C Quilty, PhD principal investigator
Centre for Addiction and Mental Health
Allan S Kaplan, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate and Cognitive Behavioral Therapy in people with Binge-Eating Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 4 inclusion and 13 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 6 Feb 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Frequency of binge episodes/days, as assessed by prospective daily binge diary (time frame: After 12 weeks of treatment). 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 6 Feb 2017.