DepressionPhase 2NCT00624858

A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression

A Phase 2 study testing naltrexone SR 32 mg/ bupropion SR 360 mg daily in people with Depression, run by Orexigen Therapeutics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: naltrexone SR 32 mg/ bupropion SR 360 mg daily
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Jul 2009
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lindner Center of HOPE
Mason, Ohio, 45040

Other trials in United States

About this study

Official title: 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.

Conditions: Depression
Being tested: naltrexone SR 32 mg/ bupropion SR 360 mg daily
Keywords: Depression, depressed, overweight, obese
Medical subject headings: Depression, Consciousness Disorders, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

naltrexone SR 32 mg/ bupropion SR 360 mg dailyDrug
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

Study groups in NCT00624858
Study group	Role	What they receive
NB32	Experimental	Naltrexone SR 32 mg/Bupropion SR 360 mg/ day Receives: Drug: naltrexone SR 32 mg/ bupropion SR 360 mg daily

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the change in depressive symptoms as measured by Montgomery-Asberg Depression Rating Scale (MADRS) total score at 12 weeks
Measured: 12 Weeks

Secondary outcomes (1)

To assess the percentage change from baseline in total body weight at 12 and 24 weeks.
Measured: 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jul 2009

First posted27 Feb 2008 (estimated)
Study startJan 2008
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00624858
Sponsor's protocol ID: NB-402
Status last verified: Oct 2012
First submitted: 19 Feb 2008
Last updated: 30 Oct 2012
Results posted: No
Data monitoring committee: No

Publications

McElroy SL, Guerdjikova AI, Kim DD, Burns C, Harris-Collazo R, Landbloom R, Dunayevich E. Naltrexone/Bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study. Prim Care Companion CNS Disord. 2013;15(3):PCC.12m01494. doi: 10.4088/PCC.12m01494. Epub 2013 Jun 20.
PubMed 24171147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00624858
Acronym / sponsor ID: NB-402
Conditions: Depression
Keywords: Depression, depressed, overweight, obese
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (estimated)
Lead sponsor: Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 27 Feb 2008 (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 a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NB32	Experimental	Drug: naltrexone SR 32 mg/ bupropion SR 360 mg dailyNaltrexone SR 32 mg/Bupropion SR 360 mg/ day

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (11 listed)

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;

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
naltrexone SR 32 mg/ bupropion SR 360 mg dailyAll 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	Drug	NB32

Primary outcome

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

1 secondary outcome

To assess the percentage change from baseline in total body weight at 12 and 24 weeks.
Time frame: 12 and 24 weeks

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 30 Oct 2012.
Derived from this study: PubMed 24171147McElroy SL, Guerdjikova AI, Kim DD, Burns C, Harris-Collazo R, Landbloom R, Dunayevich E. Naltrexone/Bupropion combination therapy in overweight or obese patients with major depressive disorder: results of a pilot study. Prim Care Companion CNS Disord. 2013;15(3):PCC.12m01494. doi: 10.4088/PCC.12m01494. Epub 2013 Jun 20.

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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.

Susan McElroy, MD principal investigator

University of Cincinnati

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 naltrexone SR 32 mg/ bupropion SR 360 mg daily in people with Depression, run by Orexigen Therapeutics, Inc 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 11 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 30 Oct 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. 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00624858, which also lists 1 linked publication.

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 Oct 2012.