Major Depressive DisorderPhase 3NCT02218008

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

A Phase 3 study testing ALKS 5461 in people with Major Depressive Disorder, run by Alkermes, Inc. at 44 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

This study will evaluate the efficacy and safety of 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?: Yes, some participants may receive a placebo
How many people: 407 participants
Where: 44 sitesin 4 countries
Study dates: Jul 2014to Oct 2016
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

Have a BMI of 18.0 to 40.0 kg/m2, inclusive
Agree to use an acceptable method of contraception for the duration of the study
Have an MDD primary diagnosis
Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Additional criteria may apply

Who cannot join

Have a current primary Axis-I disorder other than MDD
Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during their lifetime
Have attempted suicide within the past 2 years
Have a positive test for drugs of abuse
Are pregnant, planning to become pregnant, or breastfeeding

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 within 60 days
Additional criteria may apply

Trial locations and contacts

44 sites in 4 countries.

Country

City, postcode or hospital

44 sites in 4 countries

United States32 sites

Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Birmingham, Alabama, 35294
Alkermes Investigational Site
Bradenton, Florida, 34201
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Clinton, Utah, 84015
Alkermes Investigational Site
Colorado Springs, Colorado, 80910
Alkermes Investigational Site
Colton, California, 92324
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Fort Myers, Florida, 33912
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
High Point, North Carolina, 27265
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
Los Angeles, California, 90024
Alkermes Investigational Site
Melbourne, Florida, 32901
Alkermes Investigational Site
Memphis, Tennessee, 38119
Alkermes Investigational Site
New York, New York, 10168
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Portland, Oregon, 97214
Alkermes Investigational Site
Princeton, New Jersey, 08540
Alkermes Investigational Site
Saint Charles, Missouri, 63304
Alkermes Investigational Site
San Gabriel, California, 91776
Alkermes Investigational Site
Seattle, Washington, 98104
Alkermes Investigational Site
Smyrna, Georgia, 30080
Alkermes Investigational Site
Spokane, Washington, 99204
Alkermes Investigational Site
St Louis, Missouri, 63141
Alkermes Investigational Site
Wichita Falls, Texas, 76309
Alkermes Investigational Site
Winter Haven, Florida, 33880

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Germany6 sites

Alkermes Investigational Site
Berlin, 10245
Alkermes Investigational Site
Berlin, 10629
Alkermes Investigational Site
Hanover, 30159
Alkermes Investigational Site
Oranienburg, 16515
Alkermes Investigational Site
Schwerin, 19053
Alkermes Investigational Site
Stralsund, 18439

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Canada4 sites

Alkermes Investigational Site
Gatineau, J8T 8J1
Alkermes Investigational Site
Halifax, B3S 1M7
Alkermes Investigational Site
Penticton, V2A 4M4
Alkermes Investigational Site
Québec, G3K 2P8

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Puerto Rico2 sites

Alkermes Investigational Site
San Juan, 00918
Alkermes Investigational Site
San Juan, 00926

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About this study

Official title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)

This study will evaluate the efficacy and safety of ALKS 5461.

Conditions: Major Depressive Disorder
Being tested: ALKS 5461, Placebo
Keywords: Major depressive disorder (MDD), depression, Alkermes, ALKS 5461, samidorphan
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 (in addition to open-label treatment with a commercially available antidepressant)
PlaceboDrug
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Study groups in NCT02218008
Study group	Role	What they receive
High Dose	Experimental	Not described Receives: Drug: ALKS 5461
Low Dose	Experimental	Not described Receives: Drug: ALKS 5461
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Measured: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Measured: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Change From Baseline to End of Treatment in the MADRS-10
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Measured: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

Secondary outcomes (3)

Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Measured: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Remission Rate
The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.
Measured: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Number of Subjects With Adverse Events (AEs)
Measured: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

Timeline

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

Jul 2014Oct 2016

First posted15 Aug 2014 (estimated)
Study startJul 2014
Primary completionSep 2016
Study completionOct 2016

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: 407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02218008
Sponsor's protocol ID: ALK5461-207
Status last verified: Aug 2019
First submitted: 14 Aug 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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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 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
ClinicalTrials.gov ID: NCT02218008
Acronym / sponsor ID: ALK5461-207
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder (MDD), depression, Alkermes, ALKS 5461, samidorphan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 407 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Sep 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 15 Aug 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 study will evaluate the efficacy and safety of 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: 3

Arm	Type	Receives
High Dose	Experimental	Drug: ALKS 5461
Low Dose	Experimental	Drug: ALKS 5461
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (5 listed)

Have a BMI of 18.0 to 40.0 kg/m2, inclusive
Agree to use an acceptable method of contraception for the duration of the study
Have an MDD primary diagnosis
Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Additional criteria may apply

Key exclusion criteria (9 listed)

Have a current primary Axis-I disorder other than MDD
Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during their lifetime
Have attempted suicide within the past 2 years
Have a positive test for drugs of abuse

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 (in addition to open-label treatment with a commercially available antidepressant)	Drug	High Dose, Low Dose
PlaceboSublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)	Drug	Placebo

Primary outcome

Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
Time frame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).
Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Change From Baseline to End of Treatment in the MADRS-10
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

3 secondary outcomes

Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Remission Rate
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Number of Subjects With Adverse Events (AEs)
Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

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
Placebo S1	280	258
ALKS 5461 1mg/1mg S1	63	56
ALKS 5461 2mg/2mg S1	63	48
Placebo S2	0	0
ALKS 5461 1mg/1mg S2	0	0
ALKS 5461 2mg/2mg S2	0	0

Primary outcome: Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)

Time frame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo S1 n = 273	ALKS 5461 1mg/1mg S1 n = 62	ALKS 5461 2mg/2mg S1 n = 63	Placebo S2 n = 60	ALKS 5461 1mg/1mg S2 n = 62	ALKS 5461 2mg/2mg S2 n = 63
Value	-5.6 (0.34)	-6.0 (0.74)	-6.8 (0.75)	-1.5 (0.65)	-2.2 (0.67)	-3.2 (0.67)

Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2: Least Squares Mean Difference: -1.5 (95% CI -2.7 to -0.3), p = 0.018, Mixed Models Analysis

Population analysed: Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS assessment in the respective stage.

Primary outcome: Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)

Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2). Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo S1 n = 273	ALKS 5461 1mg/1mg S1 n = 62	ALKS 5461 2mg/2mg S1 n = 63	Placebo S2 n = 60	ALKS 5461 1mg/1mg S2 n = 62	ALKS 5461 2mg/2mg S2 n = 63
Value	-8.1 (0.48)	-8.8 (1.05)	-10.3 (1.06)	-2.1 (0.88)	-3.2 (0.91)	-3.7 (0.90)

Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2: Least Squares Mean Difference: -1.9 (95% CI -3.6 to -0.2), p = 0.026, Mixed Models Analysis

Primary outcome: Change From Baseline to End of Treatment in the MADRS-10

Time frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2). Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo S1 n = 273	ALKS 5461 1mg/1mg S1 n = 62	ALKS 5461 2mg/2mg S1 n = 63	Placebo S2 n = 60	ALKS 5461 1mg/1mg S2 n = 62	ALKS 5461 2mg/2mg S2 n = 63
Value	-9.2 (0.55)	-10.3 (1.19)	-10.8 (1.22)	-1.9 (0.96)	-3.4 (0.98)	-3.6 (0.98)

Placebo S1 vs ALKS 5461 2mg/2mg S1 vs Placebo S2 vs ALKS 5461 2mg/2mg S2: Least Squares Mean Difference: -1.7 (95% CI -3.6 to 0.2), p = 0.076, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks for Stage 1 and 6 weeks for Stage 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo S1	1 of 280 (0.4%)	72 of 280 (25.7%)	0 of 280
ALKS 5461 1mg/1mg S1	0 of 63 (0%)	25 of 63 (39.7%)	0 of 63
ALKS 5461 2mg/2mg S1	2 of 63 (3.2%)	28 of 63 (44.4%)	0 of 63
Placebo S2	1 of 62 (1.6%)	11 of 62 (17.7%)	0 of 62
ALKS 5461 1mg/1mg S2	0 of 62 (0%)	6 of 62 (9.7%)	0 of 62
ALKS 5461 2mg/2mg S2	0 of 63 (0%)	10 of 63 (15.9%)	0 of 63

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.
Study-specific websiteLink provided by the sponsor.

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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.

44 sites in 4 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 44 sites in 4 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 5 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 44 sites in United States, Germany, Canada, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?

Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) (time frame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect). The study lists 3 primary outcomes in all. 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 NCT02218008.

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.