- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00624858
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
October 23, 2012 updated by: Orexigen Therapeutics, Inc
An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) in Overweight or Obese Subjects With Major Depression
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Mason, Ohio, United States, 45040
- Lindner Center of HOPE
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female and male subjects must be 18 to 65 years of age;
- Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;
- Meet criteria for major depression
- Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
- Able to comply with all required study procedures and schedule;
- Able to speak and read English;
- Willing and able to give written informed consent
Exclusion Criteria:
- Obesity of known endocrine origin
- Serious medical condition
- History of drug or alcohol abuse or dependence
- Use of excluded concomitant medications
- History of surgical or device (e.g. gastric banding) intervention for obesity;
- History or predisposition to seizures
- Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
- Planned surgical procedure that can impact the conduct of the study;
- Use of investigational drug, device or procedure within 30 days prior to Screening;
- Participation in any previous clinical trial conducted by Orexigen Therapeutics;
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/ day
|
All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks. During the study, subjects will receive ancillary therapy including advice on diet and exercise |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the percentage change from baseline in total body weight at 12 and 24 weeks.
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan McElroy, MD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 26, 2008
First Posted (ESTIMATE)
February 27, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 30, 2012
Last Update Submitted That Met QC Criteria
October 23, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Body Weight
- Depression
- Depressive Disorder
- Overweight
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Alcohol Deterrents
- Dopamine Uptake Inhibitors
- Naltrexone
- Bupropion
Other Study ID Numbers
- NB-402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Lawson Health Research InstituteTerminated
Clinical Trials on naltrexone SR 32 mg/ bupropion SR 360 mg daily
-
Orexigen Therapeutics, IncCompleted
-
Orexigen Therapeutics, IncCompletedObesity | OverweightUnited States
-
Orexigen Therapeutics, IncCompletedObesity | Overweight | Nicotine DependenceUnited States
-
Orexigen Therapeutics, IncCompleted
-
Orexigen Therapeutics, IncCompletedObesity | Diabetes Mellitus, Type 2 | OverweightUnited States
-
Orexigen Therapeutics, IncCompletedObesity | OverweightUnited States
-
Orexigen Therapeutics, IncCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedMajor Depressive DisorderUnited States
-
GlaxoSmithKlineCompletedDepressive Disorder, MajorKorea, Republic of, Japan
-
Orexigen Therapeutics, IncCompleted