An Efficacy and Tolerability Study for Topiramate in Obes... | NCT00307619

Studies
An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

NCT00307619

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Status

Completed

Last Update Posted

Jan 31, 2011Estimated

Enrollment

73Actual

Phase

Phase 3

Conditions

Binge Eating

Interventions

topiramate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Apr 2005Actual

First Submitted Date

Mar 24, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2011

Last Update Posted Date

Jan 31, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the effectiveness and tolerability of topiramate compared to placebo in patients with binge eating disorder receiving Cognitive Behavior Therapy (CBT)

Detailed Description

This was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate versus placebo in obese patients with BED receiving group CBT. The aim of this trial is to investigate the efficacy and tolerability of adjunctive topiramate to CBT in obese patients with BED through improvement in binge eating, related psychopathology, and weight loss. The study hypothesis is that the patients using topiramate + CBT will loose more weight than patients using placebo + CBT.Tolerability will be investigated through reported adverse events and dropouts, with reasons for leaving the study being analyzed. The randomized patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily for 21 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Name	Type	Description	Arm Group Labels	Other Names
topiramate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight, Body Mass Index,number of binge eating and anthropometric measurements

Secondary Outcomes

Measure	Description	Time Frame
changes in blood pressure, serum triglycerides levels, serum cholesterol levels, beck depression scale scores.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have been meeting the diagnostic criteria for binge eating disorder (according to the Diagnostic and Statistical Manual for Mental Disorders - IV Edition criteria) with at least 2 days of binge eating per week and severity at least moderate defined by binge eating scale (score = 17)
BMI = > 30 kg/m2 to < 46 kg/m2
Women must be post menopausal for at least one year or surgically sterilized (hysterectomy, tubal ligation), or practice sexual abstinence or use an acceptable method of birth control (i.e. a hormonal contraceptive, spermicide plus barrier method, intrauterine device and/or vasectomized partner)

Exclusion Criteria:

Has a history or actual diagnostic of significant psychiatric disorder (schizophrenia, psychosis, major affective disorder, suicide risk, dementia, abuses alcohol or other drugs)
has a malignancy or a history of malignancy within the past 5 years (except basal cell carcinoma)
evidence of uncontrolled thyroid disorders
uncontrolled hypertension (defined as a diastolic blood pressure >110 mm/Hg and/or a systolic blood pressure >180 mm/Hg with or without medication). Hypertensive patients on medications must have been on the same dose of the same antihypertensive medication for at least two months
history or significant renal failure or glaucoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Janssen-Cilag Farmaceutica Ltda. Clinical Trial	Janssen-Cilag Farmaceutica Ltda.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17915969	Derived	Claudino AM, de Oliveira IR, Appolinario JC, Cordas TA, Duchesne M, Sichieri R, Bacaltchuk J. Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder. J Clin Psychiatry. 2007 Sep;68(9):1324-32. doi: 10.4088/jcp.v68n0901.

ID	Term
D002032	Bulimia
D056912	Binge-Eating Disorder

ID	Term
D006963	Hyperphagia
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241