Major Depressive DisorderPhase 3NCT02085135

A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 9 sites in 2 countries.

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

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: ALKS 5461
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 9 sitesin 2 countries
Study dates: Feb 2014to Sep 2014
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body mass index of 18-40 kg/m2
Have a diagnosis of MDD
Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
Have an inadequate response to current antidepressant treatment
Agree to use an approved method of birth control for the duration of the study
Additional criteria may apply

Who cannot join

Currently pregnant or breastfeeding
History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 5 years
Have attempted suicide within the past 2 years

Show all 9Show fewer

Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
Have had a significant blood loss or blood donation with 60 days of screening
Additional criteria may apply

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

United States8 sites

Alkermes Investigational Site
Allentown, Pennsylvania, 18104
Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Jacksonville, Florida, 32256
Alkermes Investigational Site
Orlando, Florida, 32806
Alkermes Investigational Site
Saint Charles, Missouri, 63304
Alkermes Investigational Site
Staten Island, New York, 10305

Other trials in United States

Canada1 site

Alkermes Investigational Site
Halifax, Nova Scotia

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Conditions: Major Depressive Disorder
Being tested: ALKS 5461
Keywords: depression, major depressive disorder, Alkermes, ALKS 5461, samidorphan, buprenorphine
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

ALKS 5461Drug
Sublingual tablet taken once daily

Study groups in NCT02085135
Study group	Role	What they receive
Titration Schedule 1	Experimental	Not described Receives: Drug: ALKS 5461
Titration Schedule 2	Experimental	Not described Receives: Drug: ALKS 5461

What is being measured

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

Number of Subjects With Adverse Events (AEs)
Measured: 8 weeks

Timeline

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

Feb 2014Sep 2014

First posted12 Mar 2014 (estimated)
Study startFeb 2014
Primary completionSep 2014
Study completionSep 2014

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 Major Depressive DisorderStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02085135
Sponsor's protocol ID: ALK5461-210
Status last verified: Aug 2019
First submitted: 7 Mar 2014
Last updated: 14 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)
ClinicalTrials.gov ID: NCT02085135
Acronym / sponsor ID: ALK5461-210
Conditions: Major Depressive Disorder
Keywords: depression, major depressive disorder, Alkermes, ALKS 5461, samidorphan, buprenorphine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 12 Mar 2014 (estimated)
Results: Posted 27 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Titration Schedule 1	Experimental	Drug: ALKS 5461
Titration Schedule 2	Experimental	Drug: ALKS 5461

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Body mass index of 18-40 kg/m2
Have a diagnosis of MDD
Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
Have an inadequate response to current antidepressant treatment

Key exclusion criteria (9 listed)

Currently pregnant or breastfeeding
History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 5 years

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
ALKS 5461Sublingual tablet taken once daily	Drug	Titration Schedule 1, Titration Schedule 2

Primary outcome

Number of Subjects With Adverse Events (AEs)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 27 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-Week Titration	34	23
2-Week Titration	32	23

Primary outcome: Number of Subjects With Adverse Events (AEs)

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	1-Week Titration n = 34	2-Week Titration n = 32
Value	27	28

Population analysed: Number of subjects who received at least 1 dose of study drug.

Adverse events

Time frame: Up to 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1-Week Titration	0 of 34 (0%)	23 of 34 (67.6%)	0 of 34
2-Week Titration	0 of 32 (0%)	28 of 32 (87.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

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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.

Sanjeev Pathak, MD study director

Alkermes, Inc.

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 9 sites in 2 countries.

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 9 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Mar 2019). 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?

Number of Subjects With Adverse Events (AEs) (time frame: 8 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 NCT02085135.

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 14 Aug 2019.